Phase 2
Completed N=106
Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
Source: ClinicalTrials.gov NCT00919633 ↗Enrolled (actual)
106
Serious AEs
17.9%
Results posted
Apr 2014
Primary outcomePrimary: Viral Load: Incidence of Sustained Virologic Response (SVR) — 4; 7; 2; 4 participants
Summary
The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Viral Load: Incidence of Sustained Virologic Response (SVR) |
4; 7; 2; 4 | — |
| SECONDARY Rapid Virologic Response (RVR) |
2; 4; 7; 11 | — |
| SECONDARY Early Virologic Response (EVR) |
7; 15; 13; 11 | — |
Eligibility Criteria
Inclusion Criteria
- Signed patient consent form
- Genotype 1 chronic HCV with detectable HCV RNA
- No previous treatment for HCV infection
- Hepatitis B and human immunodeficiency virus negative at screening visit
- Able and willing to follow contraception requirements
- Screening laboratory values, test, and physical exam within acceptable ranges
- Weight between 40 kg and 125 kg
- Proficiency in the use of the external pump infusion system
Exclusion Criteria
- Current or planned enrollment in another investigational device or drug study
- Anticipated inability to complete all clinic visits and comply with study procedures
- History of, or any current medical condition, which could impact the safety of the subject during the study
- Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV
- Alcoholism or substance abuse with <6 documented months of sobriety
- Known allergy or sensitivity to interferons or ribavirin
- Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study
Data sourced from ClinicalTrials.gov (NCT00919633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.