A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01033448
First received: December 15, 2009
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This open-label, multi-center study will evaluate the safety and tolerability an d the effect on viral activity of a combined PEGASYS and COPEGUS extended therap y in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who co mpleted 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatme nt with PEGASYS and COPEGUS and were identified as slow virological responders w ill be enrolled in this study in order to receive additional 24 weeks of treatme nt. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated tim e on study treatment is 24 weeks. The target sample size is 50-150 patients.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-Center Study Evaluating the Effect on Viral Activity and the Safety and Tolerability of Extended Treatment of Pegasys® (Peginterferon Alfa 2a ) in Combination With Copegus® (Ribavirin) in Genotype 1, 2 and 3 Chronic Hepatitis C Patients Defined as Slow Responders/Non-RVR

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: end of treatment response rate (virological), sustained viral response [ Time Frame: 24 weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability: AEs, laboratory parameters [ Time Frame: AEs: throughout study; laboratory assessments: weeks 8, 16, 24 ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: December 2009
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: COPEGUS
COPEGUS 800 mg or 1000-1200 mg po for 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
PEGASYS 180 micrograms sc once weekly for 24 weeks

  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
  • Chronic hepatitis C, genotype 1, 2, 3
  • Compensated liver disease
  • Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders

Exclusion Criteria:

  • Decompensated liver disease
  • Signs or symptoms of hepatocellular carcinoma
  • Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
  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: NCT01033448

Locations
Israel
Afula, Israel, 18101
Ashdod, Israel, 77444
Bat Yam, Israel
Beer Sheva, Israel, 84105
Haifa, Israel, 31096
Haifa, Israel, 33394
Haifa, Israel, 34362
Holon, Israel, 58100
Jerusalem, Israel, 91120
Jerusalem, Israel, 95146
Kfar Saba, Israel, 44281
Nahariya, Israel, 22100
Nazareth, Israel
Petach Tikva, Israel, 49100
Rehovot, Israel, 76100
Rishon Lezion, Israel, 75299
Safed, Israel, 13110
Tel Aviv, Israel, 67891
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: NCT01033448     History of Changes
Other Study ID Numbers: ML21778
Study First Received: December 15, 2009
Last Updated: August 26, 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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014