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
Sponsor study identifier
interventional
50
1 country
1
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
June 23, 2008
Actual (reported)June 24, 2008
Actual (reported)December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Rapid Virologic Response
4 weeks
Early Virologic Response
12 Weeks
Sustained Virologic Response
24 weeks post-treatment
Oral HDV-Interferon
Injectable HDV-Interferon + ribavarin
Naive pateints
Nonresponders
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Global Hospitals
Lakdi-ka-Pool, Hyderabad, 500 004, India
Dharmesh Kapoor, MD
Global Hospitals, Lakdi-ka-pool, Hyderabad - 500 004 India
First Submitted
June 23, 2008
First Posted
June 24, 2008
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 9, 2009
Record last verified: 2009-01
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Source: ClinicalTrials.gov.
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