Clinical trial NCT01639547: Sustained Virological Response (SVR)Rate of Pegasys Plus Ribavirin in Patients With Chronic Hepatitis C
Official title: A Randomized, Open-lable, Multicenter, Parallel Group Study to Compare SVR Rate of Pegasys Plus Ribavirin for 48 Weeks vs. 36 Weeks in Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Hepatitis C
Keywords: PEGASYS® PLUS RIBAVIRIN
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 410
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the effect of PEGASYS® (peginterferon alfa-2a 40KD) plus Robatrol® (ribavirin) combination therapy given for 36 weeks versus 48 weeks on the clearance of HCV viremia 24 weeks after treatment end

Detailed description: Pegylated interferon plus ribavirin brings a good therapeutic response and curability. However, the adverse effects and sufferings are lots. Response-guided, personalized treatment is current principle. In patients of CHC, GT1 PR treatment for 24 weeks is established in rapid virologic responders (RVR) who have low viral load before treatment. As to patients with RVR but high viral load (HVL), the treatment duration is 48 weeks that is the same as patients with complete early virologic response (cEVR). Is a shorter duration of treatment feasible for those with a good virokinetic response? The ideal treatment duration for patients of chronic hepatitis C, GT-1, high viral load with RVR has had no enough data yet. Is it really necessary to double the treatment duration (48 weeks) for patients of chronic hepatitis C, GT-1, high viral load with RVR? Is 36-week adequate for them? A multicenter trial of INDIV-2 was presented at EASL 2010. They treated CHC patients of naïve GT1 HVL and RVR for 30 weeks and got similarly good SVR as those treated for 48 weeks (85% vs. 82%).

Therefore, investigators design a randomized controlled study to investigate the SVR rates between treatment for 36 weeks and for 48 weeks in patients of CHC, GT1, HVL and RVR.

Eligibility criteria: Inclusion Criteria:

* 20\~70 years old
* Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribarivin
* Chronic hepatitis C, genotype 1, HCV-RNA \> 0.8x106 IU/ml, achieving RVR (undetectable HCV RNA at week 4) in the SoC treatment
* Patient must be able to comply with the assessments during the study
* Compensated liver disease (Child-Pugh Grade A clinical classification for patients with cirrhosis: total score ≦ 6)
* All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment with study drugs and 6 months post treatment completion

Exclusion Criteria:

* History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
* History or other evidence of decompensated liver disease
* Signs or symptoms of hepatocellular carcinoma
* Co-infection with hepatitis A, hepatitis B or human immunodeficiency virus (HIV)
* Not adequately controlled thyroid dysfunction, diabetes mellitus (HbA1c \>8.5%) or psychiatric disorders, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
* History of a severe seizure disorder or current anticonvulsant use
* History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
* Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder (e.g. due to diabetes mellitus or hypertension)
* Women with on-going pregnancy or breast feeding
* Male partners of women who are pregnant
* Subjects with any of the following laboratory abnormalities

  * Platelet count \< 90,000/mm3
  * Absolute neutrophil count \< 1,500 /mm3
  * Hemoglobin \< 12 g/dL (F), 13 g/dL (M)
  * Creatinine \> ULN
  * ALT and/or AST \> 10X ULN
  * Total serum bilirubin \> 1.5 x ULN
* Inability or unwillingness to provide written informed consent or abide by the requirements of the study

Primary outcomes:
measure: Sustained virological response
timeFrame: At 24 weeks after end of treatment
Secondary outcomes:
measure: Virological Response Rate at week 2
timeFrame: At treatment week 2
measure: Virological response at end of treatment
timeFrame: At end of treatment
measure: Correlation of virological response and SVR rate
timeFrame: At 24 weeks after end of treatment
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Show Chwan Memorial Hospital
city: Changhua County
country: Taiwan
facility: Changhua Christian Hospital
city: Keelung City
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
city: Taichung City
country: Taiwan
facility: Tungs' Taichung MetroHarbor Hospital
city: Taipei County
country: Taiwan
facility: Taipei Medical University - Shuang Ho Hospital
city: Taoyuan County
country: Taiwan
facility: Linkou Medical Center, Chang Gung Memorial Hospital
Study officials:
affiliation: Linkou Medical Center, Chang Gung Memorial Hospital
name: I-Shyan Sheen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: