Clinical Trials Logo
  1. Home
  2. Hepatitis C, Chronic
  3. NCT00217139
  4. Details
NCT00217139 Clinical Trial

A Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection

Hepatitis C, Chronic Clinical Trial

Official title:
A Phase II, Randomized, Active-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Celgosivir in Combination With Peginterferon Alfa-2b, With and Without Ribavirin, for 12 Weeks in Patients With Chronic Hepatitis C Infection (Genotype 1) Who Failed to Respond to Pegylated α Interferon-Based Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00217139
Other study ID # HCV-05-002
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated September 27, 2006
Start date September 2005
Est. completion date September 2006

Study information
Verified date September 2006
Source BioWest Therapeutics Inc
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

The objective of the study is to evaluate the safety and efficacy of celgosivir plus peginterferon alfa-2b, with or without ribavirin, for 12 weeks in patients with chronic hepatitis C genotype 1 infection.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 18-65 years of age, inclusive

- primary diagnosis of chronic HCV infection

- non-responders to previous pegylated interferon-based therapy

Exclusion Criteria:

- patients naive to interferon-based therapy for chronic HCV infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Celgosivir

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
BioWest Therapeutics Inc

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety analysis
Primary HCV viral load
See also
  Status Clinical Trial Phase
Completed NCT03413696 - Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
Completed NCT03740906 - Direct-acting Antiviral Therapy and Reinfection Among People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use in the Prison Setting
Terminated NCT02465203 - 3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study Phase 3
Completed NCT02262728 - An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease Phase 2
Completed NCT01429792 - A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) Phase 4
Completed NCT02541409 - Directly Observed Therapy for HCV in Chennai, India Phase 2
Completed NCT01846832 - A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection Phase 3
Withdrawn NCT01608737 - A Phase III Study of BI201335 in Treatment-naive and Prior Relapser Patients With Chronic Hepatitis C Infection Phase 3
Completed NCT01399619 - Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4) Phase 3
Completed NCT02113631 - Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir N/A
Completed NCT01447446 - An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C N/A
Completed NCT01435044 - Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection Phase 2
Completed NCT01435226 - GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection Phase 2
Terminated NCT01168856 - An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens N/A
Completed NCT00793793 - Safety, Antiviral Activity and PK of MRD of BI 201335 in Chronic Hepatitis C Patients Both Treatment Naive and -Experienced Phase 1
Completed NCT00725751 - Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255) N/A
Completed NCT00375661 - Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC Phase 4
Completed NCT00377182 - A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection. Phase 2
Completed NCT00704717 - Evaluation of Patient Satisfaction in Hepatitis C Patients Treated With PegIntron Pen and Rebetol in Romania (Study P04301) N/A
Completed NCT00723632 - Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED) N/A