A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)

End Stage Renal Disease Clinical Trial

Official title:

A Pilot Study to Treat Patients With Chronic HCV Genotype 1 and ESRD Receiving Hemodialysis and Naïve to Prior HCV Therapy With Peginterferon Alfa-2b, the Maximally Tolerated Ribavirin Dose and Boceprevir

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01731301
• Other study ID #: LIV01
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 16, 2012
• Last updated: November 20, 2012
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: November 2012
• Source: Liver Institute of Virginia
• Contact: Mitchell L Shiffman, MD
• Phone: 804-977-8920
• Email: mitchell_shiffman[@]bshsi.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

1. A maximally tolerated dose of ribavirin can be defined in each patient with ESRD undergoing hemodialysis.

2. Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease (ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.

3. A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis can achieve rapid virologic response (RVR), extended virologic response (eRVR) and sustained virologic response (SVR) when treated with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.

Description:

Patients with ESRD will be treated with a dose escalation of ribavirin starting from 200 mg everyday (QD) to a maximal tolerated dose. Peginterferon will then be added. Ribavirin will be dose adjusted as needed. Boceprevir will then be added. Ribavirin will be dose adjusted as needed. Patients will be monitored for eRVR and SVR. The study end-point is eRVR.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Chronic HCV defined by:

• A history of a positive anti-HCV or HCV RNA for > 6 months or

• A liver biopsy demonstrating at least portal fibrosis

• HCV genotype 1

• No prior treatment with any interferon or peginterferon preparation

• ESRD undergoing hemodialysis for at least 6 months

• Willingness not to conceive a child during treatment and for 6 months following discontinuation of treatment.

Exclusion Criteria:

• Histologic evidence of cirrhosis

• Any co-existent liver disease

• A platelet count < 90,000

• A total white blood cell (WBC) < 2.5

• An absolute neutrophil count < 1.5

• Hemoglobin < 11 gm/dl on Epoetin-alpha

• Positive test for anti-HIV

• Pregnancy of the patient or their intimate partner

• Women who are breast feeding

• Significant cardiovascular disease

• History of suicide intent, severe depression requiring hospitalization or significant psychiatric disease

• Malignancy within 5 years of enrollment except for squamous or basal cell skin cancer

• Co-existent immune disorder such as lupus, rheumatoid as arthritis, colitis, Crohns disease, sarcoidosis, etc.

• Any patient in the opinion of the investigator who would not be a satisfactory study candidate

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• End Stage Renal Disease
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• Ribavirin
Ribavirin monotherapy will be started at a dose of 100 mg daily. After each successive week the dose of ribavirin will be increased by 100 mg increments daily as long as the hemoglobin remains greater than 10 gm/dl and/or there has not been a decline in the hemoglobin by more than 2 gms/dl from the pretreatment baseline.
• Peginterferon
After the patient has remained on their maximal tolerated dose of ribavirin for 1 week peginterferon alpha-2b will be initiated at a dose of 1.0 mcg/kg/week. This dose was chosen because it is known to be equivalent in achieving SVR when compared to the 1.5 mcg/kg/dose and is associated with less bone marrow suppression. The dose of ribavirin will be adjusted as needed.
• Boceprevir
Boceprevir will be added after the patient is on stable doses of ribavirin and peginterferon. The dose of ribavirin will be adjusted as needed.

Locations

Country	Name	City	State
United States	Liver Institute of Virginia	Richmond	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Liver Institute of Virginia	Chronic Liver Disease Foundation, Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who achieve eRVR at treatment week 28	The primary end-point for evaluation will be the percentage of patients who achieve eRVR at treatment week 28.	28 weeks	No
Secondary	Tolerability of treatment	A. The ability to define the maximal tolerated dose of ribavirin. B. The ability to remain on peg-interferon alfa-2b, ribavirin and boceprevir for 24 weeks C. The percentage of patients who achieve SVR	48 weeks	Yes