Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
Study NCT ID:
NCT04166266
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2019-09-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019701', 'term': 'Hepatitis D, Chronic'}, {'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D003699', 'term': 'Hepatitis D'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'targetDuration': '7 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2019-09-12', 'studyFirstSubmitQcDate': '2019-11-15', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the natural or treated history of patients infected with HDV according to different management modalities.', 'timeFrame': 'At the end of the follow-up, december 2027', 'description': 'This is a cohort in which many events will be studied. As the objectives are multiple, no primary endpoint has been defined.'}], 'secondaryOutcomes': [{'measure': "Number of patient's reported outcomes measured with specific questionnaire", 'timeFrame': 'weeks 24, 48, end of treatment and 48 weeks after the end of treatment'}, {'measure': 'Quality of observance measured with specific questionnaire', 'timeFrame': 'weeks 24, 48, end of treatment and 48 weeks after the end of treatment'}, {'measure': 'Alcohol consumption (AUDIT-c), tobacco and cannabis use', 'timeFrame': 'weeks 24, 48, end of treatment and 48 weeks after the end of treatment'}, {'measure': 'Socio-economic situation measured with specific questionnaire', 'timeFrame': 'weeks 24, 48, end of treatment and 48 weeks after the end of treatment'}, {'measure': 'Quality of life level measured with short-form 12 (SF12) questionnaire', 'timeFrame': 'At weeks 24, 48, end of treatment and 48 weeks after the end of treatment'}, {'measure': 'Rate of patients achieving HBV DNA indetectability', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Rate of early discontinuation of treatment due to an adverse event', 'timeFrame': 'At weeks 12, 24, 48, end of treatment'}, {'measure': 'HDV RNA level', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'HDV RNA variation rate', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Breakthrough rate', 'timeFrame': 'At weeks 8, 12 and through the end of treatment (average 3 years)'}, {'measure': 'Rate of sustained virological response', 'timeFrame': 'At weeks 12, 24, 36 and 48 and through the end of treatment (average 3 years)', 'description': 'HDV RNA undetectability'}, {'measure': 'Rate of partial virological response', 'timeFrame': 'At weeks 4, 8, 12 and through the end of treatment (average 3 years)', 'description': 'reduction in Delta RNA of at least 2 log10 compared with the basal value, without undetectability'}, {'measure': 'Rate of patients achieving HBs seroconversion', 'timeFrame': 'At weeks 12, 24, 48,through the end of treatment (average 3 years), and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Virological response delay', 'timeFrame': 'At weeks 8, 12 and through the end of treatment (average 3 years)'}, {'measure': 'Number of different HDV resistance variants', 'timeFrame': 'Through treatment period, average 3 years'}, {'measure': 'Number of patients with at least one resistance variant', 'timeFrame': 'Through treatment period, average 3 years'}, {'measure': 'Fibrosis level', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Rate of adverse event', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Death rate', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Liver transplantation rate', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Number and characterization of associated treatment with analogs and/or interferon', 'timeFrame': 'At weeks 4, 8, 12 and through the end of treatment (average 3 years'}, {'measure': 'Rate of patients presenting an evolution towards hepatocellular carcinoma', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Rate of patients presenting an evolution towards cirrhosis', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)', 'description': 'in non-cirrhotic patients'}, {'measure': 'Rate of patients presenting a decompensated cirrhosis', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)', 'description': 'in non-cirrhotic patients'}, {'measure': 'Change in HBs Ag from baseline', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Rate of biochemical response', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)', 'description': 'Biochemical response is defined as ALT and aspartate aminotransferase (AST) normalization'}, {'measure': 'Rate of patients achieving hepatitis B e (HBe) Ag negativation in patient initially HBeAg- positive', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Rate of patients with appearance of anti-HBe Ab', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Rate of patients achieving HBe seroconversion', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Rate of spontaneous virological recovery', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)', 'description': 'Prolonged HDV RNA undetectability'}, {'measure': 'Rate of patients achieving HBs Ag negativation', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}, {'measure': 'Rate of patients with appearance of anti-HBs Ab', 'timeFrame': 'At weeks 12, 24, 48, end of treatment and 12, 24, 36 weeks after the end of treatment and every 24 weeks through study completion (max december 2027)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['safety', 'efficacy', 'evolution', 'treatment'], 'conditions': ['Hepatitis D, Chronic', 'Hepatitis B, Chronic']}, 'descriptionModule': {'briefSummary': 'This is a multicentre observational study with prospective and retrospective data collection and retrospective data collection and biological collection from patients with HBV/HDV co-infection.', 'detailedDescription': 'This is an observatory for patients co-infected with hepatitis B and Delta viruses. Patients will be monitored according to the usual recommendations, depending on their status:\n\n* Patients who have never received specific treatment for hepatitis Delta (untreated or receiving treatment with peginterferon alpha 2a alone) will be monitored according to current recommendations, once every 6 months;\n* Patients treated or having been treated with a specific hepatitis Delta treatment will be monitored according to the compassionate access protocol or according to the recommendations of the AMM during treatment and according to routine follow-up after the end of treatment.\n\nParticipation in research entails the following additional procedures for patients, for each line of treatment, where applicable:\n\n* Samples for the biobank,\n* Self-administered questionnaires.\n\nIn addition, as sub-studies are planned on sub-groups of patients, these sub-studies may involve additional constraints/interventions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients followed in the participating centers for their HBV/HDV co-infection are susceptible to be included.\n\nPatients who already started a specific treatment for their HDV infection will be included retrospectively, after they have signed an informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years,\n* Presenting a chronic HDV infection (positive serology),\n* Who gave his written informed consent before any intervention and the day of inclusion at the latest,\n* Affiliated to Health Insurance or to the "Aide Médicale d\'Etat" (request for exemption pending).\n\nExclusion Criteria:\n\n* Patient participating in another biomedical research with an exclusion period ongoing at inclusion,\n* Vulnerable patient (minor, adults legally protected: under judicial protection, guardianship, or supervision, persons deprived of their liberty).\n* Patients with predictable difficulties of follow-up according to the investigator.'}, 'identificationModule': {'nctId': 'NCT04166266', 'acronym': 'HEPDELTA', 'briefTitle': 'National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'National Cohort of Patients Co-infected With Hepatitis B and Delta Viruses', 'orgStudyIdInfo': {'id': 'ANRS HD EP01-HEPDELTA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with co-infection with hepatitis B and Delta viruses,', 'description': 'Blood sampling for the biobank and, in addition, as sub-studies are planned on sub-groups of patients, additional blood samples are planned for the patients in these sub-studies.', 'interventionNames': ['Other: Blood draw for the laboratory assessment']}], 'interventions': [{'name': 'Blood draw for the laboratory assessment', 'type': 'OTHER', 'description': 'Blood sampling for the biobank and, in addition, as sub-studies are planned on sub-groups of patients, additional blood samples are planned for the patients in these sub-studies.', 'armGroupLabels': ['Adults with co-infection with hepatitis B and Delta viruses,']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle FOUCHARD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU of Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Annecy', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Frederic HELUWAERT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier de la région annécienne', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dominique ROULOT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Avicenne Hospital - Hepatology', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Bobigny', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nathalie GANNE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Avicenne Hospital', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Juliette FOUCHER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Haut Lévêque Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Armand ABERGEL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Estaing Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Clichy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Tarik ASSELAH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beaujon Hospital', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Isabelle ROSA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Hospitalier Intercommunal', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Créteil', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vincent LEROY', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henri Mondor Hospital', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Dijon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne MINELLO', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bocage Hospital', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Grenoble', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Noëlle HILLERET', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Michallon Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe MATHURIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Claude Huriez Hospital', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Véronique LOUSTAUD-RATTI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dupuytren Hospital', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Dulce ALFAIATE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Croix Rousse Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérôme DUMORTIER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Edouard Herriot Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabien ZOULIM', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc BOURLIERE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'SAint Joseph Hospital', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Magdalena MESZAROS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saint Eloi Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérôme GOURNAY', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hotel Dieu Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François RAFFI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôtel-Dieu Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Albert TRAN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "l'Archet 2 Hospital", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Orléans', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Xavier CAUSSE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'La Source Hospital', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne GERVAIS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bichat-Claude Bernard Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stanislas POL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cochin Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Julie CHAS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vlad RATZIU', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'La Pitié Salpêtrière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Myriam DIEMER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lariboisière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marc-Antoine VALANTIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pitié-Salpêtrière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier CHAZOUILLERES', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saint Antoine Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline LASCOUX-COMBE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saint Louis Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Karine LACOMBE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Saint-Antoine Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rennes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline JEZEQUEL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Pontchaillou Hospital', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ghassan RIACHI', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charles Nicolle Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Simona TRIPON', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nouvel Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent ALRIC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie METIVIER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rangueil Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Tours', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': "Louis d'ALTEROCHE", 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Trousseau Hospital', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bruno ROCHE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Paul Brousse Hospital', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'COULIBALY Fatoumata', 'role': 'CONTACT', 'email': 'fatoumata.coulibaly@anrs.fr', 'phone': '0144236110', 'phoneExt': '+33'}, {'name': 'Claire FOUGEROU-LEURENT', 'role': 'CONTACT', 'email': 'claire.fougerou@chu-rennes.fr'}], 'overallOfficials': [{'name': 'Fabien ZOULIM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital de la Croix-Rousse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}