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A Multi-center, Randomized, Controlled Clinical Trial of Pegylated interferon alpha-2a (40KD) Plus Ribavirin With or Without Vitamin D in Chronic Hepatitis C

A Multi-center, Randomized, Controlled Clinical Trial of Pegylated interferon alpha-2a (40KD) Plus Ribavirin With or Without Vitamin D in Chronic Hepatitis C

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-PPC-15006199
Enrollment
Unknown
Registered
2015-04-02
Start date
2015-06-01
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

Experimental:vitamin D supplementation with pegylated interferon + ribavirin (PegIFN/RBV)
Control:pegylated interferon + ribavirin (PegIFN/RBV)

Sponsors

The First Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adult patients, 18-65 years of age; 2. Chronic hepatitis C with genotype 1 infection; 3. Detectable HCV RNA (HCV RNA >1000copies/ml); 4. Treatment Naive patients (no HCV antiviral treatment history); 5. Written informed consent signed.

Exclusion criteria

Exclusion criteria: 1. Pregnant orlactatingwomen; 2. The patients received antiviral treatment or immunotherapy before screening; 3. Co-infection with hepatitis A, B, D, E, and/or HIV; 4. Other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis, cancer, decompensated liver disease and organ transplant patients; 5. Patients with severe neurological or psychological disease; 6. Uncontrolled thyroid diseases and other immunological diseases; 7. Uncontrolled hyperglycemia or hypoglycemia and diabetes; 8. Retinopathy and other ophthalmopathy; 9. Alcohol abuse and on temperance/drug addicts; 10. The baseline prior treatment should be platelet >=90000 cell/mm3, and ANC >=1500 cell/mm3; 11. Patients with a history of severe cardiac disease, coronary artery disease, cerebrovascular disease; 12. Failed with medication control of epilepsia; 13. Contra-indication to Peginterferonalfa therapy per theChina labeling and China HCV guideline; 14. Contra-indication to Vit D therapy per the labeling; 15. Or other conditions that investigator assessed should be excluded.

Design outcomes

Primary

MeasureTime frame
Virus response rate;

Countries

China

Contacts

Public ContactXiao-bo Lu
zhengrongjiong@163.com+86 13999113773

Outcome results

None listed

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