Ignite Creation Date:
2024-05-05 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00703872
Status:
UNKNOWN
Last Update Posted:
2009-01-09
First Post:
2008-06-23
Brief Title:
HDV-Interferon in the Treatment of Chronic Hepatitis C Nonresponders and Naive Hepatitis C Patients
Sponsor:
Hepasome Pharmaceuticals
Organization:
Hepasome Pharmaceuticals
Study Overview
Official Title:
An Evaluation of Two Dose Routes of HDV-Interferon Administered With Ribavarin in the Treatment of Chronic Hepatitis C Nonresponders and Naive Hepatitis C Patients
Status:
UNKNOWN
Status Verified Date:
2009-01
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:
A Phase II Open Label Multi-Center Proof-Of-Concept Study determing whether treatment with HDV-Interferon HDV-IFN by oral or subcutaneous injection routes and ribavirin results in similar efficacy Rapid Virologic Response RVR and safety as the reported efficacy and safety with pegylated alpha-interferon-2a and ribavirin historical control in patients with chronic hepatitis C treatment naïve by oral route and non-responders by SC route respectively
Detailed Description:
Part 1 initial part - 4 weeks of treatment 28 days
All patients will complete an initial 4 weeks of treatment with HDV-Interferon HDV-IFN treatment naïve by oral route and non-responders by SC route respectively and ribavirin
The Part 1 of the study shall assess whether a 4-week treatment course with HDV-Interferon HDV-IFN orally or by subcutaneous injection and ribavirin results similar efficacy Rapid Virologic Response RVR and safety as the reported efficacy and safety with pegylated alpha-interferon-2a and ribavirin historical control in patients with chronic hepatitis C treatment naïve and non-responders
Part 2 continuation part - 44 or 20 weeks of treatment 24 weeks follow-up period
Patients with hepatitis C viral genotype 1 who achieve RVR will be treated for another 44 weeks of therapy to complete 48 weeks of active treatment followed by 24 weeks of treatment-free follow-up period
Patients with hepatitis C viral genotype 3 who achieve RVR will be treated for another 20 weeks of therapy to complete 24 weeks of active treatment followed by 24 weeks of treatment-free follow-up period
Follow-up period 24 weeks Thus in addition to treatment in Part 1 of study each completed patient with viral genotype 1 will receive 44 weeks of therapy and 24 weeks of treatment-free follow-up and viral genotype 3 patients will have 20 weeks of therapy 24 weeks of treatment study drug free follow-up
Overall study duration 72 or 48 weeks Patients with viral genotype 1 will have an overall study duration of 72 weeks 48 weeks of therapy plus 24 weeks follow-up and patients with viral genotype 3 will have an overall study duration of 48 weeks 24 weeks of therapy plus 24 weeks follow-up
All patients will complete an initial 4 weeks of treatment with HDV-Interferon HDV-IFN treatment naïve by oral route and non-responders by SC route respectively and ribavirin
The Part 1 of the study shall assess whether a 4-week treatment course with HDV-Interferon HDV-IFN orally or by subcutaneous injection and ribavirin results similar efficacy Rapid Virologic Response RVR and safety as the reported efficacy and safety with pegylated alpha-interferon-2a and ribavirin historical control in patients with chronic hepatitis C treatment naïve and non-responders
Part 2 continuation part - 44 or 20 weeks of treatment 24 weeks follow-up period
Patients with hepatitis C viral genotype 1 who achieve RVR will be treated for another 44 weeks of therapy to complete 48 weeks of active treatment followed by 24 weeks of treatment-free follow-up period
Patients with hepatitis C viral genotype 3 who achieve RVR will be treated for another 20 weeks of therapy to complete 24 weeks of active treatment followed by 24 weeks of treatment-free follow-up period
Follow-up period 24 weeks Thus in addition to treatment in Part 1 of study each completed patient with viral genotype 1 will receive 44 weeks of therapy and 24 weeks of treatment-free follow-up and viral genotype 3 patients will have 20 weeks of therapy 24 weeks of treatment study drug free follow-up
Overall study duration 72 or 48 weeks Patients with viral genotype 1 will have an overall study duration of 72 weeks 48 weeks of therapy plus 24 weeks follow-up and patients with viral genotype 3 will have an overall study duration of 48 weeks 24 weeks of therapy plus 24 weeks follow-up
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