HDV-Interferon in the Treatment of Chronic Hepatitis C Nonresponders and Naive Hepatitis C Patients
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|ClinicalTrials.gov Identifier: NCT00703872|
Recruitment Status : Unknown
Verified January 2009 by Hepasome Pharmaceuticals.
Recruitment status was: Active, not recruiting
First Posted : June 24, 2008
Last Update Posted : January 9, 2009
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Oral HDV-Interferon + ribavarin Drug: Injectable HDV-Interferon + ribavarin||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2009|
Drug: Oral HDV-Interferon + ribavarin
Injectable HDV-Interferon + ribavarin
Drug: Injectable HDV-Interferon + ribavarin
- Rapid Virologic Response [ Time Frame: 4 weeks ]
- Early Virologic Response [ Time Frame: 12 Weeks ]
- Sustained Virologic Response [ Time Frame: 24 weeks post-treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703872
|Lakdi-ka-Pool, Hyderabad, India, 500 004|
|Principal Investigator:||Dharmesh Kapoor, MD||Global Hospitals, Lakdi-ka-pool, Hyderabad - 500 004 India|