Study in patients with hepatitis C genotype 1 and insulin resistance to study the sustained virologic response and resistance profile with boceprevir, PEG-IFN and ribaviri

Phase 1

• Conditions: HCV-1 with insulin resistance; MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-002771-33-IT
• Lead Sponsor: MSD ITALIA S.R.L.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-28
• Study Completion: 2012-12-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Each subject must have >= 18 years of age.
2.Each subject must have quantifiable serum HCV-RNA
3.Each subject must have infection with HCV-1
4.Each subject must have HOMA IR > 2.5 in two determinations made 4 weeks apart
5.Each subject must have previous failure to achieve SVR with PEG-IFN plus Ribavirin given for a minimum of 12 weeks without dose reduction below 80% of the adequate doses of the two drugs.
6.Each subject must be with no/partial response or relapser
7.Each subject must have compensated liver disease with or without histologic or non-invasive evidence of liver cirrhosis
8.Each subject must have no contraindications to PEG-IFN or to Ribavirin as defined in the labels of the drugs to be used in combination with Boceprevir
9.If heterosexually active, a female subject of childbearing potential and a non vasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives until 6 months after therapy has ended (7 months for male subject)
10.Each subject must be able to adhere to dose and visit schedules
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1.Subject with coinfection with HCV genotypes other than HCV-1
2.Subject with Evidence of decompensated liver disease
3.Subject with history of ascites, hepatic encephalopathy or of bleeding varices or of severe portal hypertension
4.Subject with history or signs or symptoms or evidence of HCC.
5.Subject with other important comorbidities (Cardiovascular diseases, Type 1 diabetes or indaquately controlled type 2 diabetes, malignancies , etc)
6.Subject with Haemoglobin < 12 g/dL for females and < 13 g/dL for males
7.Subject with Neutrophils < 1500 mm3
8.Subject with Platelets < 100000 mm3
9.Subject with organ transplant
10.Subject with coinfection with HBV or HIV
11.Subject with severe psychiatric disease
12.Subject with inadequately controlled thyroid function
13.Subject with substances abuse
14.Subject with alcohol intake > 20 gr/day for females and > 30 gr/day for males
15.Subject with hypersensitivity or any other contraindication to PEG-IFN or RIBAVIRIN or to any component of the Boceprevir formulation
16.Subject with evidence of severe adverse events during previous treatment with PEG-IFN plus RIBAVIRIN, including discontinuation of therapy for severe anemia or haematologic toxicity.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified