24 VS 48-WEEK TREATMENT WITH PEG-IFN ALPHA-2A IN PATIENTS WITH GENOTYPE 2/3 CHRONIC HEPATITIS C

NCT01517308 | Withdrawn Phase 3

• 1 other identifier: C.E. Federico II 47/11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the present study is to evaluate in a cohort of patients with genotype 2/3 chronic hepatitis C, relapsers to a previous PEG-IFN + ribavirin therapy (alpha-2a or alpha-2b) the efficacy of PEG-IFNα-2a + ribavirin administered for 24 or 48 weeks. It will be evaluated whether 48 weeks of therapy may achieve better results compared to the standard duration (24 weeks).

Conditions

Chronic Hepatitis C

Keywords

HCV; Hepatitis; Genotype 2 or 3; Pegylated Interferon; Duration

Outcome Measures

Primary Outcomes (1)

• Sustained virological response (SVR)

  HCV-RNA undetectability (by the means of Real time PCR assay with a sensitivity limit of 20 UI/mL) 6 months after therapy withdrawal.

  6 months after therapy withdrawal

Study Arms (2)

Control Arm 24 weeks

ACTIVE COMPARATOR

PEG-IFN α2a 180 μg/week+ ribavirin 800 mg/die for 24 weeks

Drug: pegylated interferon alpha 2a + ribavirin

Active arm (48 weeks)

EXPERIMENTAL

PEG-IFN α2a 180 μg/week + ribavirin 800 mg/die per 48 weeks

Drug: pegylated interferon alpha 2a + ribavirin

Interventions

pegylated interferon alpha 2a + ribavirin DRUG

Comparison of different duration of drugs (48 weeks vs. 24 weeks)

Active arm (48 weeks); Control Arm 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Age more than 18 years
• Compensated liver disease with following pre-enrollment hematological parameters: Hemoglobin more than 13 g/dl in males and 12 g/dl in females; White blood cell count more than 3,000/mmc; Platelet count more than 100,000 /mmc
• Anti-nuclear antibodies (ANA) less than 1:160
• Anti-Liver-Kidney antibodies (LKM1): negative
• alpha1 fetoprotein levels less than 50 ng/ml in 3 months before enrollment and liver Ultrasound negative for focal malignant lesions.
• HBsAg: negative
• Clinical or histological diagnosis of chronic hepatitis C
• HCV-RNA: positive
• Relapse (end-of-treatment HCV-RNA negativity and positivization within 6 months after therapy withdrawal) to at-least one previous treatment of PEG-IFN (alpha2a or alpha2b) + ribavirin which should have lasted at least for 80% of the 24 planned weeks with at least 80% of total planned dose of PEG-IFN and ribavirin administered.
• Normal values of total and direct bilirubin (with the exception of indirect bilirubin due to extrahepatic factors such as Gilbert syndrome; in these cases the levels should be less than 3 mg/dL).
• Normal values of albumin and creatinin
• Normal fasting glycemia or, in case of glycemic values between 115mg/dL and 140 mg/dl (values confirmed in more than one determination) or if the patient is affected by diabetes mellitus, glycated hemoglobin should be \< 8,5%.
• Normal Thyroid Stimulating Hormone (TSH) level. Subjects under pharmacological treatment to maintain normal TSH levels can be enrolled if they fulfill other criteria.
• In case of history of diabetes or hypertension a specialist examination is required to rule out contraindication to therapy.

You may not qualify if:

• Age less than 18 years
• Women during pregnancy or breast-feeding
• Previous treatment with PEG-IFN alpha2a or alpha2b + ribavirin for more than 6 months
• Participation to any clinical trial within 30 days from enrollment in this protocol
• Subjects with solid organ transplantation (with the exception of cornea or hair transplantation)
• Subject not willing to have a counseling or to abstain from alcohol use
• Suspected hypersensitivity to PEG-Interferon alpha2a or ribavirin
• Any other cause of liver disease different from chronic hepatitis C based on anamnesis of patient or on histological evidence including but not limited to:
• HBV coinfection
• Alpha-1 antitrypsin deficiency
• Wilson disease
• Autoimmune hepatitis
• Alcoholic liver disease
• Hemoglobinopathy included but not limited to thalassemia major.
• Advanced liver diseases diagnosed through history or presence of ascites, esophageal variceal bleeding or hepatic encephalopathy

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, Naples, I-80131, Italy

Location

Related Publications (1)

• Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34. doi: 10.1056/NEJMoa066403.

  PMID: 17625124 BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Guglielmo Borgia, Professor

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 25, 2012
• Study Start: May 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 19, 2012

Record last verified: 2012-03

Locations

IT (1)