14 vs 24 Weeks HCV Treatment to Genotype 2/3 Patients With Rapid Virological Response

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00308048
First received: March 27, 2006
Last updated: July 3, 2011
Last verified: March 2006
  Purpose

Patients with HCV genotype 2 or 3 infection who have a rapid virological response to treatment are randomised to either 14 or 24 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.


Condition Intervention Phase
Hepatitis C Virus Infection
Drug: Pegylated Interferon alfa 2b and ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 14 vs 24 Weeks HCV Treatment to Genotype 2/3 Patients With Rapid Virological Response

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Sustained virological response (SVR) =HCV RNA negativity (<20 IU/ml) six months after end of treatment.

Secondary Outcome Measures:
  • Change in health related quality as measured by short from 36 (SF-36) from baseline to 6 months after end of treatment.
  • Sick leave in patients treated for 14 or 24 weeks treatment

Estimated Enrollment: 435
Study Start Date: March 2004
Estimated Study Completion Date: September 2006
Detailed Description:

Patients with HCV genotype 2 or 3 infection are currently recommended 6 months treatment with pegylated interferon alfa (2a or 2b) and ribavirin.Approximately 80% obtain sustained virological response (HCV RNA undetectable 6 months after treatment) to this approach. However, the treatment is associated with many and sometimes serious side effects. In addition, the treatment is costly also in econimical terms. Increasing the treatment duration beyond 6 months does not increase the response rate. Shorter treatment has only been assessed in small trials, but the results have been encouraging.

In this randomised, open label,multicenter phase 3 trial with acitive controls patients are treated with pegylated interferon alfa 2a (PegIntron (R), Schering Plough NJ)(1,5 mcg/kg)and ribavirin (Rebetol (R), Schering Plough, NJ) (800-1400mg based on weight)for 4 weeks. Those who are HCV RNA negative at week 4 (<50 IU; Cobas Amplicor Monitor Test, Roche Diagnostic) are defined as rapid virological responders and randomised to either an additional 10 or 20 weeks combination treatment. Patients who are HCV RNA positive are all treated for 20 more weeks. The endpoint is sustained virological response defined as undetectable HCV RNA 24 weeks after end of treatment.

Our hypothesis is that there is no important difference in the effect in the two groups.

This is a non-inferiority trial. The smallest difference considered to be clinically important is 10%. Thus to state "non-inferiority" the 95% confidence interval of the observed difference between the groups shall not overlap 10%. Both intention to treat and and per protocol analyses will be published. Conclusion will be conservative and based on the analysis who detect the biggest difference.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

HCV RNA positive Genotype 2 or 3 Treatment naive Raised ALT

-

Exclusion Criteria:

Active substance abuse Poorly controlled psychiatric disease Decompensated cirrhosis HBsAg positive Anti-HIV positive Suffering from other significant concurrent medical conditions including chronic liver diseases -

  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: NCT00308048

Locations
Norway
Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Schering-Plough
Investigators
Principal Investigator: Olav Dalgard, MD PhD Ullevaal University Hospital, Oslo, Norway
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00308048     History of Changes
Other Study ID Numbers: P03720
Study First Received: March 27, 2006
Last Updated: July 3, 2011
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Oslo University Hospital:
Interferon
Pegylated interferon
Pegylated interferon alfa 2b
Hepatitis C
Genotype 2
Genotype 3
Rapid virological response
Short treatment
14 weeks treatment
health related quality of life
sick leave
Injecting drug use

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Interferons
Interferon-alpha
Peginterferon alfa-2b
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 16, 2014