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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01429792
First received: September 5, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

This multi-center study will evaluate the viral response in patients with chroni c hepatitis C, genotype 1, 2, 3 & 4 on standard anti-viral treatment with Pegas ys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 & 3) or 4 8 weeks (genotype 1 & 4). Patients identified as slow responders/non-rapid virol ogical responders will be eligible for an additional 24 weeks of treatment.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin [Copegus]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Rate of genotype 1 patients with partial early viral response (pEVR, a 2-log decrement but with detectable HCV RNA at Week 12 of standard treatment) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Rate of genotype 1 patients with complete early viral response (cEVR, undetectable HCV RNA at Week 12 of standard treatment) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Rate of genotype 1 patients with pEVR at Week 12 and undetectable HCV RNA at Week 24 [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Rate of genotype 2 & 3 patients not achieving rapid viral response (RVR, defined as undetectable HCV RNA at Week 4 of standard treatment) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Rate of genotype 2 & 3 patients achieving virological response at Week 24 (EOT - end of treatment, defined as undetectable HVC RNA) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of genotype 4 patients with partial EVR [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Rate of genotype 4 patients with complete EVR [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Rate of genotype 4 patients with pEVR at Week 12 and undetectable HCV RNA at Week 24 [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]

Enrollment: 940
Study Start Date: September 2008
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: peginterferon alfa-2a [Pegasys]
standard treatment, subcutaneously weekly
Drug: ribavirin [Copegus]
standard treatment, orally daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
  • Documented pre-treatment HCV RNA quantitative result
  • Compensated liver disease (Child-Pugh Grade A)
  • Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)

Exclusion Criteria:

  • Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
  • Co-infection with active hepatitis A and/or hepatitis B
  • History or evidence of a medical condition associated with liver disease other than HCV
  • Signs and symptoms of hepatocellular carcinoma
  • History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
  • Therapy with antineoplastic treatment </= 6 months prior to study day
  • Diabetes mellitus in subjects receiving an insulin therapy
  • Evidence of severe retinopathy
  • Pregnant or breast-feeding women, and male partners of women who are pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429792

Locations
Israel
Afula, Israel, 18101
Ashdod, Israel, 77444
Ashkelon, Israel, 78278
Bat Yam, Israel
Beer Sheva, Israel, 84105
Beer Sheva, Israel, 8410101
Haifa, Israel, 33394
Haifa, Israel, 34362
Haifa, Israel, 31096
Holon, Israel, 58100
Jerusalem, Israel, 91120
Jerusalem, Israel, 95146
Kfar Saba, Israel, 44281
Nahariya, Israel, 22100
Nazareth, Israel
Petach Tikva, Israel
Petach Tikva, Israel, 49100
Ramat Gan, Israel, 52621
Rehovot, Israel, 76100
Rishon Lezion, Israel, 75299
Safed, Israel, 13110
Tel Aviv, Israel, 64353
Tel Aviv, Israel, 67891
Tel Aviv, Israel, 6423906
Tiberias, Israel
Zerifin, Israel, 70300
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01429792     History of Changes
Other Study ID Numbers: ML21779
Study First Received: September 5, 2011
Last Updated: July 14, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014