Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C

Kawin

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis c

Treatments: Drug: PEG-IFN-SA /RBV; Drug: Pegasys /RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01903278

KAWIN-002-2

Details and patient eligibility

About

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 the treatment of Chronic hepatitis C who have not been previously treated with Interferon.

Full 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 group (Peginterferon alfa-2a (Pegasys) plus RBV), 216 subjects for genotype 2,3 and 504 subjects for non-genotype2,3 will be enrolled. Accordingly, PEG-IFN-SA once weekly and RBV twice a day (bid) are given for 24 weeks and 48 weeks respectively to the HCV genotype 2,3 and the HCV non-genotype 2,3 .

Enrollment: 719 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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719 participants in 4 patient groups

PEG-IFN-SA /RBV T1(Genotype2,3)

Experimental group

Description:

PEG-IFN-SA/RBV, 1.5μg/kg/week im and RBV 1000mg-1200mg/d po bid（BW\<75kg,1000mg/d; BW≥75kg, 1200mg/d）,24 weeks

Treatment:

Drug: PEG-IFN-SA /RBV

Pegasys /RBV C1(Genotype 2,3)

Active Comparator group

Description:

Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW\<75kg，1000mg/d；BW≥75kg，1200mg/d）for 24 weeks

Treatment:

Drug: Pegasys /RBV

PEG-IFN-SA /RBV T2(Non-genotype 2,3)

Experimental group

Description:

PEG-IFN-SA 1.5μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW\<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks

Treatment:

Drug: PEG-IFN-SA /RBV

Pegasys /RBV C2(Non-genotype 2,3)

Active Comparator group

Description:

Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW\<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks

Treatment:

Drug: Pegasys /RBV