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

Hepatitis C Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00308048
• Other study ID #: P03720
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2006
• Last updated: July 3, 2011
• Start date: March 2004
• Est. completion date: September 2006

Study information

• Verified date: March 2006
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus Infection
• Virus Diseases

Intervention

Drug:
• Pegylated Interferon alfa 2b and ribavirin

Locations

Country	Name	City	State
Norway	Ullevaal University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Ullevaal University Hospital	Schering-Plough

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Dalgard O, Bjøro K, Hellum KB, Myrvang B, Ritland S, Skaug K, Raknerud N, Bell H. Treatment with pegylated interferon and ribavarin in HCV infection with genotype 2 or 3 for 14 weeks: a pilot study. Hepatology. 2004 Dec;40(6):1260-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response (SVR) =HCV RNA negativity (<20 IU/ml) six months after end of treatment.
Secondary	Change in health related quality as measured by short from 36 (SF-36) from baseline to 6 months after end of treatment.
Secondary	Sick leave in patients treated for 14 or 24 weeks treatment