Chronic Hepatitis CPhase 1HCV/HemophilNCT01704521
Viral Kinetics in HCV Clearance in Subjects With Hemophilia
A Phase 1 study testing PegInterferon, Ribavirin and Telaprevir in people with Chronic Hepatitis C and Hemophilia, run by Kenneth Sherman at 1 site in United States.
Trial summary
This study will examine viral dynamic responses in subjects with chronic hepatitis C and hemophilia when treated with pegylated interferon + ribavirin and telaprevir. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, Hemophilia
- What is being tested?
- PegInterferon, Ribavirin and Telaprevir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Oct 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Hemophilia A or B
- HCV RNA positive (PCR or branched-chain DNA Methods), Genotype 1 (a/b, mixed and unknown subtype)
- Chronic HCV infection evidenced by HCV serology, HCV RNA or liver enzyme abnormalities present at least 6 months prior to enrollment
- Liver biopsy or non-invasive marker that permits fibrosis staging within 12 months of enrollment. If a biopsy was not performed within 1 year, non-invasive markers may be utilized during screening period. Cirrhosis is not an exclusion factor
- Age ≥ 18 years
- Prior HCV treatment naïve or experienced
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- HCV viral load detectable during screening period
- Absence of exclusion criteria
- Sexually active subjects (both male and female) must agree and commit to the use of a medically acceptable form of contraception for the duration of the study and for 6 months following the last dose of study medication. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices or properly used barrier contraception.
Who cannot join
- Hemoglobin <11
- Pregnancy (during screening period or any time during treatment)
- females, that are planning to become pregnant or are breastfeeding
- males, whose partner is pregnant or is planning to become pregnant
- HIV Infection
- Prior History of:
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- Hepatitis B (HBsAG negative - must have documentation of negative results within one year prior to enrollment or during screening period if not performed in that time window
- Homozygotic alpha-1-anti-trypsin (a1AT) deficiency - documentation of a1AT level <80 (at anytime prior to screening). If <80, phenotype testing should not demonstrate zz phenotype. All other phenotypes are not exclusionary,
- History of Homozygotic Genetic Hemochromatosis (at anytime prior to enrollment) with evidence of iron overload requiring phlebotomy,
- Autoimmune markers (antinuclear antibody (ANA) and/or antismooth muscle antibody (ASMA)) >1:160.
- Any other significant liver disease or process (to be determined by the investigator). Non-alcoholic fatty-liver disease (NAFLD) is not an exclusion.
- History of Decompensated liver disease evidenced by any prior history of hepatic encephalopathy (Grade 2 or higher), ascites, variceal bleeding; Platelet count < 100,000
- Active thyroid disease (OK if on thyroid replacement with normal thyroid-stimulating hormone (TSH); if TSH abnormal must have normal free thyroid index)
- Chronic renal insufficiency, defined as creatinine clearance < 50 ml/min. (estimated by Modification of Diet in Renal Disease (MDRD) formula)
- Life-threatening disease processes that could preclude completion of trial in opinion of investigator.
- Any condition which the investigator feels will preclude safe completion of the treatment regimen including severe psychiatric disorders, active alcohol or recreational drug abuse.
- Inability to provide informed consent.
- Use of systemic corticosteroids or immunomodulatory drugs within 1 month (Nasal steroids are permitted.)
- Uncontrolled seizure disorder (in opinion of investigator)
- Concurrent autoimmune processes with active disease that may be exacerbated by interferon-based therapies (e.g. Crohn's Disease, Rheumatoid arthritis) in the opinion of the investigator. Psoriasis permitted if controlled with topical medications at the time of study enrollment.
- Use of prohibited medications (as described in the telaprevir package insert) within 14 days of the first dose of study medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Viral Kinetic Models of HCV Clearance in Hemophiliacs With Telaprevir
This study will examine viral dynamic responses in subjects with chronic hepatitis C and hemophilia when treated with pegylated interferon + ribavirin and telaprevir.
Read the detailed description
Previous clinical trials for treatment of chronic hepatitis C have excluded subjects with hemophilia from participating.
- Conditions
- Chronic Hepatitis C, Hemophilia
- Being tested
- PegInterferon, Ribavirin, Telaprevir
- Keywords
- Hepatitis C, HCV, Hemophilia
- Medical subject headings
- Hepatitis C, Chronic, Hemophilia A, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegInterferonDrug
RibavirinDrug
TelaprevirDrug
| Study group | Role | What they receive |
|---|---|---|
| Lead-In | Active comparator | Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin Receives: Drug: PegInterferon; Drug: Ribavirin; Drug: Telaprevir |
| No Lead-in | Active comparator | Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegIntereron + Ribavirin Receives: Drug: PegInterferon; Drug: Ribavirin; Drug: Telaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Sustained Virological Response at Week 12 (SVR12)
Viral kinetic assessment using SVR 12 to either "lead-in" 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment.
Measured: Post-treatment at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Sherman
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Vertex Pharmaceuticals Incorporated, Genentech, Inc.
- Responsible party
- Sponsor-investigator, Kenneth Sherman, University of Cincinnati
- Investigators
- Kenneth E Sherman, MD, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704521
- Sponsor's protocol ID
- 12053004
- Other IDs
- R34HL109334
- Acronym
- HCV/Hemophil
- Status last verified
- Mar 2015
- First submitted
- 5 Oct 2012
- Last updated
- 6 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Kinetic Models of HCV Clearance in Hemophiliacs With Telaprevir
- ClinicalTrials.gov ID
- NCT01704521
- Acronym / sponsor ID
- HCV/Hemophil / 12053004
- Conditions
- Chronic Hepatitis C, Hemophilia
- Keywords
- Hepatitis C, HCV, Hemophilia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kenneth ShermanUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Vertex Pharmaceuticals Incorporated, Genentech, Inc.
- Study start
- Dec 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Posted 6 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine viral dynamic responses in subjects with chronic hepatitis C and hemophilia when treated with pegylated interferon + ribavirin and telaprevir.
Detailed description
Previous clinical trials for treatment of chronic hepatitis C have excluded subjects with hemophilia from participating.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lead-In | Active comparator | Drug: PegInterferon, Drug: Ribavirin, Drug: TelaprevirKinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin |
| No Lead-in | Active comparator | Drug: PegInterferon, Drug: Ribavirin, Drug: TelaprevirKinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegIntereron + Ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Hemophilia A or B
- HCV RNA positive (PCR or branched-chain DNA Methods), Genotype 1 (a/b, mixed and unknown subtype)
- Chronic HCV infection evidenced by HCV serology, HCV RNA or liver enzyme abnormalities present at least 6 months prior to enrollment
- Liver biopsy or non-invasive marker that permits fibrosis staging within 12 months of enrollment. If a biopsy was not performed within 1 year, non-invasive markers may be utilized during screening period. Cirrhosis is not an exclusion factor
- Age ≥ 18 years
Key exclusion criteria (21 listed)
- Hemoglobin <11
- Pregnancy (during screening period or any time during treatment)
- HIV Infection
- Prior History of:
- History of Decompensated liver disease evidenced by any prior history of hepatic encephalopathy (Grade 2 or higher), ascites, variceal bleeding; Platelet count < 100,000
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 |
|---|---|---|
| PegInterferon | Drug | Lead-In, No Lead-in |
| Ribavirin | Drug | Lead-In, No Lead-in |
| Telaprevir | Drug | Lead-In, No Lead-in |
Primary outcome
Number of Participants With Sustained Virological Response at Week 12 (SVR12)
Time frame: Post-treatment at week 12
Viral kinetic assessment using SVR 12 to either "lead-in" 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kenneth E Sherman, MD, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PegInterferon, Ribavirin and Telaprevir in people with Chronic Hepatitis C and Hemophilia, run by Kenneth Sherman 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 9 inclusion and 21 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: finished, as of the sponsor's last update on 6 Apr 2015. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Sustained Virological Response at Week 12 (SVR12) (time frame: Post-treatment at week 12). 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 6 Apr 2015.