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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-17011156
Enrollment
Unknown
Registered
2017-04-16
Start date
2017-05-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatitis C

Interventions

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

Sponsors

People's hospital of jurong affiliated by Jiangsu university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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

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 51umol/L. 2. Ccr 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.).

Design outcomes

Primary

MeasureTime frame
HCV-RNA;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactJisheng Jing

The people's hospital of Jurong city

jrjjs2008@sina.com+86 13862430718

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026