Chronic Hepatitis CPhase 4NCT01731301
A Pilot Study to Treat Patients With Chronic Hepatitis C Virus (HCV) Genotype 1 and End-Stage Renal Disease (ESRD)
A Phase 4 study testing Ribavirin, Peginterferon and Boceprevir in people with Chronic Hepatitis C and End Stage Renal Disease, run by Liver Institute of Virginia at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, End Stage Renal Disease
- What is being tested?
- Ribavirin, Peginterferon and Boceprevir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Liver Institute of Virginia
Richmond, Virginia, 23226
Mitchell L Shiffman, MD, 804-977-8920, mitchell_shiffman@bshsi.org
Mitchell L Shiffman, MD
About this study
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
- 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.
Read the 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.
- Conditions
- Chronic Hepatitis C, End Stage Renal Disease
- Being tested
- Ribavirin, Peginterferon, Boceprevir
- Keywords
- Chronic hepatitis C, HCV, End stage renal disease, ESRD, Boceprevir, Ribavirin, Peg-interferon, Triple therapy
- Medical subject headings
- Hepatitis C, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
Also called Rebetol
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.
PeginterferonDrug
Also called PegIntron, Rebetol and Victrelis
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.
BoceprevirDrug
Also called Victralis
Boceprevir will be added after the patient is on stable doses of ribavirin and peginterferon. The dose of ribavirin will be adjusted as needed.
| Study group | Role | What they receive |
|---|---|---|
| Ribavirin, peginterferon, boceprevir | Experimental | The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir. Receives: Drug: Ribavirin; Drug: Peginterferon; Drug: Boceprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 weeks
Secondary outcomes (1)
Tolerability of treatment
- 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
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liver Institute of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Chronic Liver Disease Foundation
- Responsible party
- Sponsor
- Investigators
- Mitchell L Shiffman, MD, Principal investigator, Liver Institute of Virginia, Bon Secours Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731301
- Sponsor's protocol ID
- LIV01
- Status last verified
- Nov 2012
- First submitted
- 16 Nov 2012
- Last updated
- 22 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01731301
- Acronym / sponsor ID
- LIV01
- Conditions
- Chronic Hepatitis C, End Stage Renal Disease
- Keywords
- Chronic hepatitis C, HCV, End stage renal disease, ESRD, Boceprevir, Ribavirin, Peg-interferon, Triple therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Liver Institute of VirginiaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Chronic Liver Disease Foundation
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ribavirin, peginterferon, boceprevir | Experimental | Drug: Ribavirin, Drug: Peginterferon, Drug: BoceprevirThe efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibavirinAlso: RebetolRibavirin 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. | Drug | Ribavirin, peginterferon, boceprevir |
| PeginterferonAlso: PegIntron, Rebetol and VictrelisAfter 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. | Drug | Ribavirin, peginterferon, boceprevir |
| BoceprevirAlso: VictralisBoceprevir will be added after the patient is on stable doses of ribavirin and peginterferon. The dose of ribavirin will be adjusted as needed. | Drug | Ribavirin, peginterferon, boceprevir |
Primary outcome
Percentage of patients who achieve eRVR at treatment week 28
Time frame: 28 weeks
The primary end-point for evaluation will be the percentage of patients who achieve eRVR at treatment week 28.
1 secondary outcome
Tolerability of treatment
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell L Shiffman, MD principal investigator
Liver Institute of Virginia, Bon Secours Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ribavirin, Peginterferon and Boceprevir in people with Chronic Hepatitis C and End Stage Renal Disease, run by Liver Institute of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mitchell L Shiffman, MD (804-977-8920, mitchell_shiffman@bshsi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who achieve eRVR at treatment week 28 (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2012.