A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
This study is not yet open for participant recruitment.
Verified November 2012 by Liver Institute of Virginia
Sponsor:
Liver Institute of Virginia
Collaborators:
Merck
Chronic Liver Disease Foundation
Information provided by (Responsible Party):
Liver Institute of Virginia
ClinicalTrials.gov Identifier:
NCT01731301
First received: November 16, 2012
Last updated: November 20, 2012
Last verified: November 2012
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Purpose
- A maximally tolerated dose of ribavirin can be defined in each patient with ESRD undergoing hemodialysis.
- 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.
- 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C End Stage Renal Disease |
Drug: Ribavirin Drug: Peginterferon Drug: Boceprevir |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Liver Institute of Virginia:
Primary Outcome Measures:
- Percentage of patients who achieve eRVR at treatment week 28 [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]The primary end-point for evaluation will be the percentage of patients who achieve eRVR at treatment week 28.
Secondary Outcome Measures:
- Tolerability of treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]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
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ribavirin, peginterferon, boceprevir
The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.
|
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.
Other Name: Rebetol
Drug: 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.
Other Name: PegIntron, Rebetol and Victrelis
Drug: 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.
Other Name: Victralis
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731301
Contacts
| Contact: Mitchell L Shiffman, MD | 804-977-8920 | mitchell_shiffman@bshsi.org |
| Contact: April G. Long, NP | 804-977-8920 | april_long@bshsi.org |
Locations
| United States, Virginia | |
| Liver Institute of Virginia | Not yet recruiting |
| Richmond, Virginia, United States, 23226 | |
| Contact: Mitchell L Shiffman, MD 804-977-8920 mitchell_shiffman@bshsi.org | |
| Principal Investigator: Mitchell L Shiffman, MD | |
Sponsors and Collaborators
Liver Institute of Virginia
Merck
Chronic Liver Disease Foundation
Investigators
| Principal Investigator: | Mitchell L Shiffman, MD | Liver Institute of Virginia, Bon Secours Health System |
More Information
No publications provided
| Responsible Party: | Liver Institute of Virginia |
| ClinicalTrials.gov Identifier: | NCT01731301 History of Changes |
| Other Study ID Numbers: | LIV01 |
| Study First Received: | November 16, 2012 |
| Last Updated: | November 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Liver Institute of Virginia:
|
Chronic hepatitis C HCV End stage renal disease ESRD |
Boceprevir Ribavirin Peg-interferon Triple therapy |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Kidney Diseases Kidney Failure, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Flaviviridae Infections Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Ribavirin Peginterferon alfa-2b Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013