Concentration-Controlled Ribavirin for the Treatment of Patients With Chronic Hepatitis C Virus Infection

NCT01097395 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 08-1198K23DK082621
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if concentration-controlled ribavirin dosing can achieve a targeted level of plasma exposures and if it appears safe and effective compared with standard weight-based ribavirin dosing. Forty, previously treatment-naive participants with genotype 1 disease will be randomized to receive concentration-guided or standard weight-based ribavirin. Peginterferon alfa 2a,ribavirin, and telaprevir will be provided through the study.

Conditions

Hepatitis C Virus

Keywords

ribavirin; pharmacokinetics; Hepatitis C virus

Outcome Measures

Primary Outcomes (1)

• Ribavirin AUC-12 Variability

  Demonstrate that concentration-controlled ribavirin dosing can achieve a targeted level of plasma exposure with reduced variability in the steady-state area-under-the-concentration-time curve (AUC0-12) compared with standard weight-based ribavirin dosing

  steady state (~weeks 9-10)

Secondary Outcomes (2)

• Safety - Absolute Hemoglobin Declines

  from baseline through end of treatment, up to 48 weeks

• Sustained Virologic Response (i.e., Cure)

  assessed 12 weeks after stopping treatment

Study Arms (2)

Standard Weight-Based Ribavirin Dosing

ACTIVE COMPARATOR

1000 mg daily in patients weighing \<75 kg and 1200 mg daily in patients weighing ≥ 75 kg

Drug: ribavirin

Concentration-Controlled Ribavirin Dosing

EXPERIMENTAL

Dose adjusted based on first dose AUC0-12

Drug: ribavirin

Interventions

ribavirin DRUG

Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12

Concentration-Controlled Ribavirin Dosing; Standard Weight-Based Ribavirin Dosing

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic HCV-infected men and women
• years
• HCV genotype 1
• Deemed ready for HCV treatment by hepatology provider and patient

You may not qualify if:

• previous treatment with interferon, peginterferon, investigational HCV drugs, boceprevir, or ribavirin;
• baseline absolute neutrophil count (ANC) \< 1000/mm3,
• platelets \< 100,000/mm3,
• hemoglobin \< 12 g/dL for women and \< 13 g/dL for men;
• HIV positive serostatus;
• HBV positive serostatus;
• decompensated liver disease (i.e., ascites, history of esophageal variceal bleeding, hepatic encephalopathy);
• autoimmune hepatitis
• hemoglobinopathy (e.g., sickle cell anemia, thalassemia)
• Cockcroft and Gault estimated creatinine clearance \< 50 mL/min;
• alcohol or illicit drug use that in the opinion of the investigator would interfere with study participation and/or impact study results
• for females, active pregnancy or any intent to become pregnant during study period or for up to 6 months after completing treatment
• for males, a pregnant female partner or intent to impregnate a female during study period or for up to 6 months after completing treatment
• for both sexes an unwillingness to use two forms of contraception during the study period and for 6 months after completing treatment. While on telaprevir and for 2 weeks following discontinuation of telaprevir, females must use two non-hormonal forms of contraception;
• history of significant or unstable cardiac disease including severe coronary artery disease (unstable angina, recent myocardial infarction, chest pain with exertion) or congestive heart failure;

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• Wu LS, Rower JE, Burton JR Jr, Anderson PL, Hammond KP, Baouchi-Mokrane F, Everson GT, Urban TJ, D'Argenio DZ, Kiser JJ. Population pharmacokinetic modeling of plasma and intracellular ribavirin concentrations in patients with chronic hepatitis C virus infection. Antimicrob Agents Chemother. 2015 Apr;59(4):2179-88. doi: 10.1128/AAC.04618-14. Epub 2015 Feb 2.

  PMID: 25645847 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Jennifer Kiser
• Organization: University of Colorado

jennifer.kiser@cuanschutz.edu

3037246131

Study Officials

• Jennifer J Kiser, PharmD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: April 1, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 16, 2021
• Results First Posted: September 16, 2021

Record last verified: 2021-08

Locations

US (1)