Ignite Creation Date:
2024-05-06 @ 7:40 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02577029
Status:
TERMINATED
Last Update Posted:
2019-04-12
First Post:
2015-10-14
Brief Title:
Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus HBV
Sponsor:
Arrowhead Pharmaceuticals
Organization:
Arrowhead Pharmaceuticals
Study Overview
Official Title:
A Multicenter Open-Label Study to Evaluate ARC-520 Administered Alone and in Combination With Other Therapeutics in Patients With Chronic Hepatitis B Virus HBV Infection MONARCH
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Company decision to discontinue trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MONARCH
Brief Summary:
Patients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir ENT or tenofovir TDF andor pegylated interferon PEG IFN alpha 2a therapy and be evaluated for safety and efficacy
Detailed Description:
This is a multicenter open-label study of ARC-520 based treatment regimens administered to patients with HBeAg positive or HBeAg negative immune active chronic Hepatitis B Virus HBV infection of various genotypes or patients with Hepatitis D Virus HDV Eligible patients naive to previous treatment and who have signed an Ethics Committee - approved informed consent will be enrolled and will receive ARC-520 alone or ARC-520 plus additional treatments such as entecavir ETV or tenofovir TDF andor pegylated interferon alpha 2a PEG IFN therapy The study may initially involve up to a total of 96 eligible chronic HBV and HDV infected patients Patients in all cohorts will receive a total of 13 doses of ARC-520 at 2mgkg or 4 mgkg Patients will undergo the following evaluations at regular intervals during the study medical history physical examinations vital sign measurements blood pressure heart rate respiratory rate and temperature weight adverse events assessment AEs 12-lead ECGs liver fibrosis testing concomitant medication assessment blood sample collection for hematology coagulation chemistry exploratory Pharmacodynamic PD measures urinalysis HBV serology cytokines Follicle Stimulating Hormone FSH testing post-menopausal females and pregnancy testing for females of childbearing potential Clinically significant changes including AEs will be followed until resolution until the condition stabilizes until the event is otherwise explained or until the patient is lost to follow-up For each patient the duration of the study is approximately 96 weeks from enrolment to last visit Prior to enrolment there is a 60 day screening period Addition of new cohorts and additional treatment regimens are anticipated for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-005499-46 | EUDRACT_NUMBER | None | None |