A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism

Chronic Hepatitis C Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01441804
• Other study ID #: TAHG1IL-28BCC
• Status: Recruiting
• Phase: Phase 3
• First received: September 24, 2011
• Last updated: September 28, 2013
• Start date: May 2011
• Est. completion date: August 2014

Study information

• Verified date: September 2013
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Cai Qingxian, doctor
• Phone: +86013760857996
• Email: cqx200000[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Patients with HCV genotype 1 and IL28B CC Polymorphism who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age > 18 years

• Serum Hepatitis C RNA > 10,000IU/mL

• Hepatitis C virus genotype 1

• IL28B CC polymorphism

Exclusion Criteria:

• Previous treatment for chronic Hepatitis C

• clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml

• HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease

• Contraindications to PR-based treatment:

• Uncontrolled psychiatric illness

• Active substance dependency

• Known autoimmune disorder

• Untreated thyroid disease

• Uncontrolled seizure disorder

• Pregnancy, lactation or inability to maintain contraception

• Chronic kidney disease w/ estimated GFR< 60

• ANC<1.5/nl, Hb<12g/dl, or platelets<75/nl

• Clinical or biochemical evidence of decompensated liver disease including:

• History of encephalopathy

• Ascites

• Variceal bleeding

• Bilirubin > 3g/dl or INR > 1.5

• Life threatening disorder with expected median survival less than 5 years

• Inability to comply with drug regimens or testing schedule required for study

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
• Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
• Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
• Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks

Locations

Country	Name	City	State
China	Panyu People's Hospital	Guangzhou	Guangdong
China	The Eighth People's Hospital of Guangzhou	Guangzhou	Guangdong
China	The Third Affliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Zhongshan second people's hospital	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response (SVR)	Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment	24 weeks after the end of treatment	No
Secondary	Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment		baseline, 24 weeks after the end of treatment	No
Secondary	Sick leave in patients treated for 24 or 48 weeks treatment		48 weeks	Yes