Status:
COMPLETED
A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C
Lead Sponsor:
Beijing Kawin Technology Share-Holding Co., Ltd.
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This dose-escalating study is to evaluate the efficacy and the safety of different doses of a new bio-product Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and...
Detailed Description
Total 200 subjects will be randomized and enrolled into four groups proportionally receiving experimental drug of high dose, middle dose, low dose and positive-control drug. Treatment duration will be...
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
- 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
- Hepatotoxic drugs was used for a long time within past 6 months
- 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 not within the normal range
- Serum creatine kinase\> 3 ULN
- Positive thyroid antibodies (A-TPO, A-TG)
- Therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1 etc. within past 6 months or an anticipated usage during the period of study
- Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs
- Severe autoimmune diseases; psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.); Serious blood disorders (all kinds of anemia, hemophilia, etc.); Severe kidney disease (chronic kidney disease, renal insufficiency, etc.); poorly controlled digestive diseases; endocrine disorders such as thyroid disease and diabetes; severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.); cardiovascular diseases (hypertension, uncontrolled coronary atherosclerotic heart disease, heart failure, etc.); retinal disease; malignancies; or unsuitable for study considered by clinician
- Function organs transplant
- 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 :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT01908335
Start Date
October 1 2012
End Date
July 1 2014
Last Update
October 20 2014
Active Locations (52)
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1
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
2
First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
3
Guangdong General Hospital
Guangzhou, Guangdong, China
4
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China