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Treatment with Peg-interferon alfa-2a and ribavirin in patients with hepatitis HCV-related, with or without HIV co-infection, and end stage renal disease on dialysis - ND

Treatment with Peg-interferon alfa-2a and ribavirin in patients with hepatitis HCV-related, with or without HIV co-infection, and end stage renal disease on dialysis - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-023245-30-IT
Enrollment
Unknown
Registered
2010-12-24
Start date
2011-02-02
Completion date
Unknown
Last updated
2012-05-23

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

Conditions

Chonic hepatitis HCV-related MedDRA version: 9.1 Level: SOC Classification code 10019805 MedDRA version: 9.1 Level: SOC Classification code 10038359

Interventions

Trade Name: COPEGUS*168CPR RIV 200MG Pharmaceutical Form: Tablet INN or Proposed INN: Ribavirin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Trade Name: PE

Sponsors

ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Chronic hepatitis C - End stage renal disease(eGFR =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Age65 years; - Patients oin treatment with immunomodulant or antineoplastic drugs; - cirrhosis; - Hematopoietic system disorders; - Baseline Hb<8 gr/dl and/or Neutrophyls count<1000/mmc and/or platelet count<100000/mmc; - History of epilepsy, psychiatric disorders, cardiovascular diseases in the last 6 months befor study entry, decompensated diabetes, respiratory disorders; - Immunologic diseases that require steroid therapy; - Ocular diseases; - Acute infectious diseases; - Transplanted patients; - Allergy to study drugs.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate safety, efficacy and tolerability of combination treatment with Peg-IFN and Ribavirin in a dosage TDM-guided, in patients with chronic hepatitis HCV-related, with or without HIV co-infection, and renal impairment (GFR<50(ml/min/1.73 mq) on dialysis and in those proposed for renal transplantation;Secondary Objective: - To evaluate the rate of sustained virological response 6 months after the stop of the treatment; - To evaluate the safety parameters` changes during the treatment; - To evaluate the proportion of patients transplanted after the treatment; - To design a PK model in order to optimize ribavirin dose in patients with end stage renal disease in dialysis.;Primary end point(s): To evaluate safety, efficacy and tolerability of combination treatment with Peg-IFN and Ribavirin in a dosage TDM-guided, in patients with chronic hepatitis HCV-related, with or without HIV co-infection, and renal impairment (GFR<50(ml/min/1.73 mq) on dialysis and in those proposed for renal transplantation—

Countries

Italy

Outcome results

None listed

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