A real-world study: comparison of the safety and efficacy between the treatment of interferon plus ribavirin and DAAs in blood donors with chronic hepatitis C

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-OPN-17011156
• Date of registration: 2017-04-16
• Prospective Registration: Yes
• Primary sponsor: People's hospital of jurong affiliated by Jiangsu university
• Public title: A real-world study: comparison of the safety and efficacy between the treatment of interferon plus ribavirin and DAAs in blood donors with chronic hepatitis C
• Scientific title: A real-world study: comparison of the safety and efficacy between the treatment of interferon plus ribavirin and DAAs in blood donors with chronic hepatitis C
• Date of first enrolment: 2017-05-01
• Target sample size: PR group:200;DAA group:200;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=18855
• Study type: Observational study
• Study design: Non randomized control
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Jisheng Jing
• Affiliation: The people's hospital of Jurong city

• Name: Wei Ye
• Affiliation: The second hospital of Nanjing

Key inclusion & exclusion criteria

Inclusion criteria: 1. Diagnosis of the chronic hepatitis c is in accordance with the chinese guideline of prevention and treatment of hepatitis C;
2. HCV-RNA=15IU/mLAnti-HCV(+);
3. The history of paid blood donation;
4. Treatment-nave chronic hepatitis C patients without hepatic cirrhosis. The diagnosis of cirrhosis need to be in accordance with at least one of the criterias as follow:
(1) the result of hepatic biopsy suggests cirrhosis(for example, Metavir=4 of Ishak= 5);
(2) the detection of FibroScan suggests cirrhosis(= 12.5 kPa);
(3) the detection of ultrasound or CT of liver suggests cirrhosis.
5. Women of childbearing age have no amenorrhea, pregnancy blood test(-), the patients of childbearing age(including men or their partners) have no plan of pregnancy during the period of treatment and after 6 months of treatment;
6. Volunteered to participate in this clinical trial and patients can understand and sign informed consents.
Exclusion criteria: 1. Patients with contraindication of interferon will not accept the treatment of interferon, including: pregnancy, mental illness (for example the serious depression), uncontrolled epilepsy, No withdrawal of alcohol and/or drug use, uncontrolled autoimmune diseases, decompensated cirrhosis, heart disease with symptoms, thyroid disease, retinal disease, psoriasis, past history of depression, uncontrolled high blood pressure and diabetes, neutrophil counts < 1.0 x 10^9/L and (or), platelet count < 50 x 10^9/L, total bilirubin > 51umol/L.
2. Ccr<50mL/min;
3. Uncontrolled endocrine system diseases (diabetes (HbA1c > 7.0%), thyroid disease, etc.);
4. Severe cardiovascular diseases (uncontrolled high blood pressure (systolic blood pressure=160mmHg and/or diastolic blood pressure=100 mmHg, New York cardiac function class (NYHA) ? or above, the myocardial infarction within 6 months prior to screening, percutaneous transluminal coronary angioplasty within 6 months prior to screening, unstable angina, uncontrolled arrhythmias, etc.);
5. Severe blood system diseases (all kinds of anemia, hemophilia, etc.);
6. Severe renal disease (chronic kidney disease, renal insufficiency);
7. Severe digestive system disease(gastrointestinal ulcers, colitis, etc.);
8. Severe respiratory disease (pulmonary infection, chronic obstructive pulmonary disease and pulmonary interstitial diseases, etc.).

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic hepatitis C

Intervention(s)

PR group:interferon-a plus ribavirin;DAA group:DAAs;

Primary Outcome(s)

HCV-RNA;

Secondary Outcome(s)

liver function;Anti-HCV;ultrasound of abdomen;renal function;routine blood test;routine urine test;blood electrolyte;blood fat;Blood coagulation function;Venous blood sugar;glycosylated hemoglobin;ceruloplasmin;AFP;electrocardiogram;Fibroscan detection;

Source(s) of Monetary Support

Clinical science and technology development fund projects of jiangsu university