Ignite Creation Date:
2024-05-06 @ 9:58 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03123653
Status:
UNKNOWN
Last Update Posted:
2020-02-05
First Post:
2017-04-19
Brief Title:
To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
To Study the Efficacy of PEG-IFN Alpha in HBeAg Negative Chronic Hepatitis B Patients After Stopping Nucleotide Analogue Therapy
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study populationPerson with HBeAg negative CHB on TDFETV for more than 1 year
Study designProspectiveInterventional single arm study
Sample size All the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years
Intervention Peg IFN 2b 15mcgkg once every week for 48 weeks
Monitoring and assessment LFTHBV DNA and HbsAg at baseline 4 weeks 12 weeks24 weeks48 weeks 72 weeks and 96 weeks CBC every month and Thyroid function Test every 3rd month
Adverse effects The most frequently reported side effects of IFN-based therapy are flu-like symptoms headache fatigue myalgia alopecia and local reaction at the injection site Peg-IFN have myelosuppressive effects however neutropenia1000mm3 and thrombocytopenia 500000 mm3 are not common unless patients already have cirrhosis
Study designProspectiveInterventional single arm study
Sample size All the patients fulfilling the inclusion criteria will be included in first 6 months and subsequently followed up for 2 years
Intervention Peg IFN 2b 15mcgkg once every week for 48 weeks
Monitoring and assessment LFTHBV DNA and HbsAg at baseline 4 weeks 12 weeks24 weeks48 weeks 72 weeks and 96 weeks CBC every month and Thyroid function Test every 3rd month
Adverse effects The most frequently reported side effects of IFN-based therapy are flu-like symptoms headache fatigue myalgia alopecia and local reaction at the injection site Peg-IFN have myelosuppressive effects however neutropenia1000mm3 and thrombocytopenia 500000 mm3 are not common unless patients already have cirrhosis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None