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

NCT ID: NCT01903278

Last Updated: 2015-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 719 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-08-31

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

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 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 .

Conditions

Chronic Hepatitis c

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

PEG-IFN-SA /RBV

Intervention Type: DRUG

Pegasys /RBV C1(Genotype 2,3)

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

Group Type: ACTIVE_COMPARATOR

Pegasys /RBV

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

PEG-IFN-SA /RBV

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Pegasys /RBV

Intervention Type: DRUG

Interventions

PEG-IFN-SA /RBV

Intervention Type: DRUG

Pegasys /RBV

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Kawin Technology Share-Holding Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Cheng jun

vice president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheng jun, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Ditan Hospital

Locations

First Affiliated Hospital of Lanzhou University

Lanzhou, Gansu, China

Guangzhou Eighth People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital Southern Medical Unbiversity

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Third Affiliated Hospital, Hebei Medical University

Shijiazhuang, Hebei, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Tongji Hospital, Tongji Medical College Huazhong University of Science ＆ Technology

Wuhan, Hubei, China

Union hospital, Tongji Medical College Huazhong University of Science ＆ Technology

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Xiangya Hospital Central-South University

Changsha, Hunan, China

Jiangsu province hospital

Nanjing, Jiangsu, China

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Affiliated Hospital of Jilin University

Changchun, Jilin, China

Yanbian University Hospital (Yanbian Hospital)

Yanji, Jilin, China

The Sixth People's Hospital of Shenyang

Shenyang, Liaoning, China

First Affiliated Hospital Of Medical College of Xian Jiaotong University

Xi'an, Shaanxi, China

Second Affiliated Hospital Of Medical College of Xian Jiaotong University

Xi'an, Shaanxi, China

Tangdu Hospital，Fourth Military Medical University

Xi'an, Shaanxi, China

Jinan Infectious Disease Hospital

Jinan, Shandong, China

Qilu Hospital of Shandong university

Jinan, Shandong, China

Qingdao Municipal Hospital

Qingdao, Shandong, China

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Sichuan Academy of Medical Science ＆Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

302 Military Hospital of China

Beijing, , China

Beijing Ditan Hospital, Capital Medical University

Beijing, , China

Beijing Youan Hospital, Capital Medical University

Beijing, , China

Beijing Youyi Hospital, capital Medical University

Beijing, , China

General Hospital of Beijing Military Region

Beijing, , China

Peking University First Hospital

Beijing, , China

Peking University People's Hospital

Beijing, , China

Chongqing Southwest Hospital

Chongqing, , China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Shanghai Public Health Clinical Center

Shanghai, , China

Tianjin Infectious Disease Hospital

Tianjin, , China

Countries

China

Other Identifiers

KAWIN-002-2

Identifier Type: -

Identifier Source: org_study_id