Status:
COMPLETED
Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C
Lead Sponsor:
Beijing Kawin Technology Share-Holding Co., Ltd.
Conditions:
Chronic Hepatitis c
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study is to confirm the potential effects and assess the safety of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and Ribavirin（RBV） in t...
Detailed Description
Total 720 subjects are divided into two groups and treated separately according to the HCV genotype（genotype 2,3 and non-genotype 2,3). With 2:1 ratio between experimental group and positive-control g...
Eligibility Criteria
Inclusion
- Age 18- 65 years
- Body Mass Index (BMI) 18-30
- Chronic hepatitis C , diagnosed according to Chinese guideline of Hepatitis C (year 2004)
- Detectable serum HCV-RNA by quantitative polymerase chain reaction assay and positive anti-HCV antibody
- Female subjects of childbearing age with no history of menopause and negative pregnancy test, both female and male( including their partners ) subjects were required to conduct adequate contraception since screening until the 6 months after treatment
- Volunteered to participate in this study, understood and signed an informed consent
Exclusion
- Previous IFN treated patients
- Hepatotoxic drugs was systematically used more than two weeks within past 6 months
- Systemic therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1, etc more than two weeks within past 6 months, not including corticosteroid nasal sprays, inhaled steroids and / or topical steroids
- Co-infection with HAV, HBV, HEV, EBV, CMV and HIV
- Evidences of hepatic decompensation, including but not limited to serum total bilirubin\> 2 times the upper limit of normal (ULN); serum albumin \<35g/L; prothrombin activity (PTA) \<60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade
- Diagnosed with primary hepatocellular carcinoma or supported by evidences including but not limited to AFP\> l00ng/ml, suspicious liver nodules by imaging examinations
- Liver diseases from causes other than HCV infection, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.
- White blood cell count \<3×109/L; Neutrophil count\<1.5×109/L; platelet count\<90×109/L; hemoglobin below the lower limit of normal
- Serum creatinine above the ULN
- Serum creatine kinase\> 3 ULN
- Diabetes mellitus or Poorly controlled Thyroid Diseases
- Poorly controlled hypertension (systolic blood pressure\> 140mmHg, or diastolic blood pressure\> 90 mmHg) with hypertension -related retinal lesions
- Immunodeficiency or autoimmune diseases including but not limited to inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, scleroderma, Sjogren's syndrome, autoimmune thrombocytopenia, etc.
- Psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.)
- Severe cardiovascular diseases (New York Heart Association functional class (NYHA) Ⅲ level and above, myocardial infarction occurred within past 6 months or PTCA performed within past 6 months, unstable angina, uncontrolled arrhythmias)
- Serious blood disorders (all kinds of anemia, hemophilia, etc.)
- Severe kidney disease (chronic kidney disease, renal insufficiency, etc.)
- Serious digestive diseases (gastrointestinal ulcers, colitis, etc.)
- Severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.)
- Retinal disease (retinal exfoliation, macular hole, retinal tumors, etc.)
- Malignancies
- Function organs transplant
- Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs
- Evidence of alcohol or drug abuse (average alcohol consumption male\> 40g / day, female\> 20g / day)
- Pregnant or lactating women
- Usage of prohibition drugs in this study
- Participated in other clinical trials 3 months prior to the screening
- Unwilling to sign the informed consent and adhere to treatment requirements
- Other conditions not suitable for study judged by investigators
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
719 Patients enrolled
Trial Details
Trial ID
NCT01903278
Start Date
June 1 2013
End Date
August 1 2015
Last Update
September 25 2015
Active Locations (41)
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1
First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
2
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
3
Nanfang Hospital Southern Medical Unbiversity
Guangzhou, Guangdong, China
4
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China