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

Chronic Hepatitis c Clinical Trial

Official title:

Multi-center, Randomized, Open-label, Parallel-group, Active Controlled Study for the Efficacy and Safety of Pegylated Recombinant Consensus Interferon Variant Solution for Injection in the Treatment of Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903278
• Other study ID #: KAWIN-002-2
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2013
• Last updated: September 24, 2015
• Start date: June 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Beijing Kawin Technology Share-Holding Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 719
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 a1, 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) ? 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• PEG-IFN-SA /RBV

• Pegasys /RBV

Locations

Country	Name	City	State
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	The First Affiliated Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central-South University	Changsha	Hunan
China	Sichuan Academy of Medical Science &Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Chongqing Southwest Hospital	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing
China	Guangzhou Eighth People's Hospital	Guangzhou	Guangdong
China	Nanfang Hospital Southern Medical Unbiversity	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Jinan Infectious Disease Hospital	Jinan	Shandong
China	Qilu Hospital of Shandong university	Jinan	Shandong
China	First Affiliated Hospital of Lanzhou University	Lanzhou	Gansu
China	First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu province hospital	Nanjing	Jiangsu
China	The Second Hospital of Nanjing	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Qingdao Municipal Hospital	Qingdao	Shandong
China	Shanghai Public Health Clinical Center	Shanghai
China	The Sixth People's Hospital of Shenyang	Shenyang	Liaoning
China	Third Affiliated Hospital, Hebei Medical University	Shijiazhuang	Hebei
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin Infectious Disease Hospital	Tianjin
China	The First Teaching Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
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	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	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan
China	Yanbian University Hospital (Yanbian Hospital)	Yanji	Jilin
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Kawin Technology Share-Holding Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SVR (sustained virologic response)	defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of SVR (sustained virologic response) defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at 24 weeks after the end of treatment	24 weeks after 24 or 48 weeks of study therapy	No
Secondary	RVR(rapid virologic response)	defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4	weeks 4 of study therapy	No
Secondary	cEVR (complete early virologic response)	defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 12	weeks 12 of study therapy	No
Secondary	ETVR( end of treatment virologic response)	defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at the end of treatment	weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3	No
Secondary	eRVR ( extended rapid virologic response)	defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA < 15 IU/mL) at weeks 4 and 12	weeks 4 and 12 of study therapy	No
Secondary	No-responses	defined as the proportion of patients who had less than a <2 log IU/ml plasma HCV RNA decline at weeks 12 or had detectable plasma HCV RNA at weeks 24	weeks 12 or weeks 24 of study therapy	No
Secondary	Breakthrough	defined as the proportion of patients who had detectable plasma HCV RNA at any point during treatment after virological response( undetectable plasma HCV RNA)	weeks 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3	No
Secondary	Relapse	defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after the then	12 and 24 weeks after 24 or 48 weeks of study therapy	No