InfectionPhase 3NCT01821963
Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)
A Phase 3 study testing Pegylated Interferon Alfa 2a, Ribavirin and Telaprevir in people with Infection, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if the antiviral combination of telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the virus from coming back after the liver transplant. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Infection
- What is being tested?
- Pegylated Interferon Alfa 2a, Ribavirin and Telaprevir
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Feb 2014
- Phase
- Phase 3
- 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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged ≥ 18 and ≤ 70 years
- Detectable Hepatitis C Virus ribonucleic acid (HCV-RNA) in serum
- HCV genotype 1 infection
- Child-Pugh-Turcotte (CPT) score < 7 and Model for End-Stage Liver Disease (MELD) score < 18
- PegIFN alfa-2a/RBV-naïve or previously treated patients (partial responders, null responders and relapsers)
- Hepatocellular carcinoma within transplant criteria in the United Network for Organ Sharing (UNOS) Region IV:
Show all 10Show fewer
- Single lesion up to 6 cm, or
- Two or three lesions with largest no greater than 5 cm and the total tumor diameter no greater than 9 cm
- Listed for liver transplantation
- Willingness to give written consent and agree to double contraception
Who cannot join
- Decompensated cirrhosis
- Baseline platelet count less than 35,000/µL
- Baseline hemoglobin level less than 10 g/dL
- Baseline absolute neutrophil count less than 750/mm3
- Baseline creatinine clearance < 50 mL per min.
- Women with a positive pregnancy test at baseline or men whose female partners are pregnant or are contemplating pregnancy
- Intolerance or contraindications to PegIFN alfa-2a/RBV use per standard treatment guidelines
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Telaprevir in Combination With Standard of Care in Hepatitis C Genotype 1 Infection in Patients With Hepatocellular Carcinoma Awaiting Liver Transplantation
The goal of this clinical research study is to learn if the antiviral combination of telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the virus from coming back after the liver transplant.
Telaprevir, PegIFN alfa-2a, and RBV are different antiviral drugs that work in combination at different stages of the HCV infection to stop the virus.
Read the detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take telaprevir 3 times a day. You will take RVB by mouth 2 times a day. You will receive PEGIFN alfa-2a by an injection under the skin 1 time a week.
Study Visits:
On the first day you take the study drug:
- You will have an eye exam performed by the study doctor.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis virus.
- You will be asked about any drugs you are taking or side effects you may be having.
Every Week while you are on study:
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis C virus. If part of the blood sample is left over after the Hepatitis C testing, it will be stored in the laboratory as a back-up sample, in case the original samples get lost. This sample may also be used to check if the Hepatitis C virus has become resistant to the study drug. No extra blood will be drawn for this storage.
- You will be asked about any drugs you are taking or side effects you may be having.
- At Weeks 12, 24, 36, and 42, urine will be collected to check for infection and any other side effects to the drugs.
If you can become pregnant, you will have a urine pregnancy test every 4 weeks
Length of Treatment:
You may continue receiving the antiviral therapy for up to 48 weeks, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits.
Follow-Up Visits:
Beginning the day after you stop taking antiviral therapy (or the day of transplantation, whichever comes first), you will have up to 24 weeks of follow-up testing performed. About 4 and 20 weeks after your last dose:
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis C virus.
- You will be asked about any side effects you may be having.
- At week 4 only, urine will be collected to check for infection and any other side effects to the drugs.
This is an investigational study. Telaprevir, PegIFN alfa-2a, and RBV are all FDA approved and commercially available for the treatment of HCV infection. The use of these drugs in preventing the HCV infection is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Infection
- Being tested
- Pegylated Interferon Alfa 2a, Ribavirin, Telaprevir
- Keywords
- Infection, Hepatitis C Genotype 1 Infection, Hepatitis C virus, HCV, Hepatocellular Carcinoma, HCC, Liver Transplantation, Pegylated Interferon Alfa 2a, PegIFN alfa-2a, Ribavirin, RBV, Telaprevir, Incivek, Antiviral drugs
- Medical subject headings
- Infections, Hepatitis C, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Interferon Alfa 2aDrug
Also called PegIFN
Starting dose: 180 mcg subcutaneously once weekly.
RibavirinDrug
Starting dose: 1,000 mg by mouth daily.
TelaprevirDrug
Also called Incivek
Starting dose: 750 mg by mouth 3 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir | Experimental | Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care pegylated interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for telaprevir 750 mg taken orally 3 times a day. Receives: Drug: Pegylated Interferon Alfa 2a; 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 Undetectable Viral Load 12 Weeks Post-transplant
The primary endpoint is number of participants with undetectable viral load at 12 weeks post-transplant (Post-transplant virological response, (PTVR)) which is defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) 12 weeks after liver transplantation). In order to have undetectable HCV RNA viral load after transplant, participants need to have undetectable viral load before the liver transplant.
Response rate based on the modified intent-to-treat (ITT) population where ITT population is defined as those patients who have achieved an undetectable HCV-RNA level before the transplant. If patients drop out the study early due to severe toxicity or treatment failure including treatment-related death, they will be counted as non-responders when evaluating the response rate.
Measured: 12 weeks post-transplant, up to 48 weeks for overall monitoring
Secondary outcomes (1)
Sustained Virological Response (SVR)
Sustained virological response (SVR) defined as a single undetectable HCV-RNA measurement 12 weeks after the 48-week treatment period for those still waiting for transplantation. The treatment duration will be summarized with descriptive statistics. Additional analyses based on evaluable patients also conducted regarding the PTVR response rate. The evaluable patients are defined as those patients who complete at least 16 weeks of treatment and have the 12 weeks post-transplant response measurement. The rate will also be computed stratified by the HCV treatment time (i.e., the 48-week HCV treatment versus less than 48 week HCV treatment) considering the different times under HCV. The SVR rate will be estimated, along with the exact 95% confident interval.
Measured: 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Low referral rate due to new therapeutic options.
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 InfectionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Responsible party
- Sponsor
- Investigators
- Harrys A. Torres, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821963
- Sponsor's protocol ID
- 2012-0977
- Status last verified
- Sep 2020
- First submitted
- 27 Mar 2013
- Last updated
- 24 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telaprevir in Combination With Standard of Care in Hepatitis C Genotype 1 Infection in Patients With Hepatocellular Carcinoma Awaiting Liver Transplantation
- ClinicalTrials.gov ID
- NCT01821963
- Acronym / sponsor ID
- 2012-0977
- Conditions
- Infection
- Keywords
- Infection, Hepatitis C Genotype 1 Infection, Hepatitis C virus, HCV, Hepatocellular Carcinoma, HCC, Liver Transplantation, Pegylated Interferon Alfa 2a
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low referral rate due to new therapeutic options.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Posted 6 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if the antiviral combination of telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the virus from coming back after the liver transplant.
Telaprevir, PegIFN alfa-2a, and RBV are different antiviral drugs that work in combination at different stages of the HCV infection to stop the virus.
Detailed description
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take telaprevir 3 times a day. You will take RVB by mouth 2 times a day. You will receive PEGIFN alfa-2a by an injection under the skin 1 time a week.
Study Visits:
On the first day you take the study drug:
- You will have an eye exam performed by the study doctor.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis virus.
- You will be asked about any drugs you are taking or side effects you may be having.
Every Week while you are on study:
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis C virus. If part of the blood sample is left over after the Hepatitis C testing, it will be stored in the laboratory as a back-up sample, in case the original samples get lost. This sample may also be used to check if the Hepatitis C virus has become resistant to the study drug. No extra blood will be drawn for this storage.
- You will be asked about any drugs you are taking or side effects you may be having.
- At Weeks 12, 24, 36, and 42, urine will be collected to check for infection and any other side effects to the drugs.
If you can become pregnant, you will have a urine pregnancy test every 4 weeks
Length of Treatment:
You may continue receiving the antiviral therapy for up to 48 weeks, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over after the follow-up visits.
Follow-Up Visits:
Beginning the day after you stop taking antiviral therapy (or the day of transplantation, whichever comes first), you will have up to 24 weeks of follow-up testing performed. About 4 and 20 weeks after your last dose:
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 2 teaspoons) will be drawn for routine tests and to check for the hepatitis C virus.
- You will be asked about any side effects you may be having.
- At week 4 only, urine will be collected to check for infection and any other side effects to the drugs.
This is an investigational study. Telaprevir, PegIFN alfa-2a, and RBV are all FDA approved and commercially available for the treatment of HCV infection. The use of these drugs in preventing the HCV infection is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir | Experimental | Drug: Pegylated Interferon Alfa 2a, Drug: Ribavirin, Drug: TelaprevirTriple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care pegylated interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for telaprevir 750 mg taken orally 3 times a day. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or females aged ≥ 18 and ≤ 70 years
- Detectable Hepatitis C Virus ribonucleic acid (HCV-RNA) in serum
- HCV genotype 1 infection
- Child-Pugh-Turcotte (CPT) score < 7 and Model for End-Stage Liver Disease (MELD) score < 18
- PegIFN alfa-2a/RBV-naïve or previously treated patients (partial responders, null responders and relapsers)
Key exclusion criteria (7 listed)
- Decompensated cirrhosis
- Baseline platelet count less than 35,000/µL
- Baseline hemoglobin level less than 10 g/dL
- Baseline absolute neutrophil count less than 750/mm3
- Baseline creatinine clearance < 50 mL per min.
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 |
|---|---|---|
| Pegylated Interferon Alfa 2aAlso: PegIFNStarting dose: 180 mcg subcutaneously once weekly. | Drug | Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir |
| RibavirinStarting dose: 1,000 mg by mouth daily. | Drug | Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir |
| TelaprevirAlso: IncivekStarting dose: 750 mg by mouth 3 times a day. | Drug | Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir |
Primary outcome
Number of Participants With Undetectable Viral Load 12 Weeks Post-transplant
Time frame: 12 weeks post-transplant, up to 48 weeks for overall monitoring
The primary endpoint is number of participants with undetectable viral load at 12 weeks post-transplant (Post-transplant virological response, (PTVR)) which is defined as undetectable Hepatitis C Virus ribonucleic acid (HCV-RNA) 12 weeks after liver transplantation). In order to have undetectable HCV RNA viral load after transplant, participants need to have undetectable viral load before the liver transplant. Response rate based on the modified intent-to-treat (ITT) population where ITT population is defined as those patients who have achieved an undetectable HCV-RNA level before the transplant. If patients drop out the study early due to severe toxicity or treatment failure including treatment-related death, they will be counted as non-responders when evaluating the response rate.
1 secondary outcome
Sustained Virological Response (SVR)
Time frame: 60 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Harrys A. Torres, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegylated Interferon Alfa 2a, Ribavirin and Telaprevir in people with Infection, run by M.D. Anderson Cancer Center 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 10 inclusion and 7 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: stopped early, as of the sponsor's last update on 24 Sep 2020. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mar 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 Undetectable Viral Load 12 Weeks Post-transplant (time frame: 12 weeks post-transplant, up to 48 weeks for overall monitoring). 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 24 Sep 2020.