Clinical trial NCT01441804: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Hepatitis C
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2011-09-28
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sustained virological response (SVR)
timeFrame: 24 weeks after the end of treatment
Secondary outcomes:
measure: Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment
timeFrame: baseline, 24 weeks after the end of treatment
measure: Sick leave in patients treated for 24 or 48 weeks treatment
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Eighth People's Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Panyu People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan second people's hospital
state: Guangdong
Study officials:
affiliation: The Third Affliated Hospital of Sun Yat-sen University
name: Gao Zhiliang, Doctor
role: STUDY_CHAIR
affiliation: The Third Affliated Hospital of Sun Yat-sen University
name: Zhao Zhixin, Doctor
role: STUDY_DIRECTOR
affiliation: The Third Affliated Hospital of Sun Yat-sen University
name: Zhang Xiaohong, Doctor
role: PRINCIPAL_INVESTIGATOR
References: