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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:
ClinicalTrials.gov Identifier:
NCT01033448
First Posted: December 16, 2009
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. 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 time 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
Intervention Model: Single Group Assignment
Masking: None (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:
  • End of Treatment Response Rate at Week 72 in Genotype 1 [ Time Frame: Week 72 ]
    End of treatment response rate at Week 72 was reported for genotype 1.

  • End of Treatment Response in Genotype 2 and 3 [ Time Frame: Week 48 ]
    End of treatment response rate at Week 48 was reported for genotype 2 and 3.

  • Sustained Viral Response (SVR) Rates in CHC Genotype 1 [ Time Frame: Week 96 ]
    Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.

  • SVR Rates in Genotype 2 and 3. [ Time Frame: Week 72 ]
    Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.


Secondary Outcome Measures:
  • Percentage of Participants With Adverse Event (AE) [ Time Frame: Week 96 ]
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT01033448


Locations
Israel
Haemek Hospital; Gastroenterology
Afula, Israel, 18101
Clalit City Ashdod MC; Liver Clinic
Ashdod, Israel, 77444
Batyamon; Liver Unit
Bat Yam, Israel
Soroka Medical Center; Gastroenterology
Beer Sheva, Israel, 84105
Rambam Medical Center; Gastroenterology - Liver Unit
Haifa, Israel, 31096
Bnei-Zion Medical Center; Gastroenterology
Haifa, Israel, 33394
Carmel Hospital; Liver Unit
Haifa, Israel, 34362
Wolfson Hospital; Gastroenterology Unit
Holon, Israel, 58100
Hadassah Hospital; Liver Unit
Jerusalem, Israel, 91120
Clalit Strauss MC
Jerusalem, Israel, 95146
Meir Medical Center; Gastroenterology
Kfar Saba, Israel, 44281
Naharyia / Western Galilee MC; Gastro Unit
Nahariya, Israel, 22100
Holy Family Medical Center; Gastroenterology
Nazareth, Israel
Rabin Medical Center; Gastroenterology - Liver Unit
Petach Tikva, Israel, 49100
Kaplan Medical Center; Gastroenterology Unit
Rehovot, Israel, 76100
Clalit Pinsker Rishon; Liver Clinic
Rishon Lezion, Israel, 75299
Rebecca Sieff Medical Center; Liver Unit
Safed, Israel, 13110
Maccabi Health Services MC
Tel Aviv, Israel, 67891
Poria Hospital; Gastroenterology
Tiberias, Israel
Assaf Harofeh; Gastroenterology
Zerifin, Israel, 6093000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01033448     History of Changes
Other Study ID Numbers: ML21778
First Submitted: December 15, 2009
First Posted: December 16, 2009
Results First Submitted: May 5, 2017
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
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
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs