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14 Vs 24 Weeks HCV Treatment to Genotype 2/3 Patients With Rapid Virological Response
This study has been completed.
First Received: March 27, 2006   No Changes Posted
Sponsors and Collaborators: Ullevaal University Hospital
Schering-Plough
Information provided by: Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00308048
  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 III

MedlinePlus related topics: Hepatitis Hepatitis C
Drug Information available for: Ribavirin Interferon alfa-2a Interferon alfa-2b Peginterferon Alfa-2b Interferon alfa-n1 Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: 14 Vs 24 Weeks HCV Treatment to Genotype 2/3 Patients With Rapid Virological Response

Further study details as provided by Ullevaal 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
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:
Study ID Numbers: P03720
Study First Received: March 27, 2006
Last Updated: March 27, 2006
ClinicalTrials.gov Identifier: NCT00308048     History of Changes
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Ullevaal 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

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Immunologic Factors
Ribavirin
Interferons
Hepatitis, Viral, Human
Quality of Life
Angiogenesis Inhibitors
Antiviral Agents
Hepatitis
Virus Diseases
Digestive System Diseases
Peginterferon alfa-2b
Hepatitis C
Interferon Alfa-2a
Interferon Alfa-2b

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

ClinicalTrials.gov processed this record on May 06, 2009