Hepatitis CPhase 4NCT01415141
Peginterferon and Ribavirin, With or Without Telaprevir, for Genotype 1 Hepatitis C and IL28B CC Polymorphism
A Phase 4 study testing Peginterferon alfa-2a, Ribavirin and telaprevir in people with Hepatitis C, run by University of Vermont at 2 sites in United States.
Trial summary
Chronic hepatitis C is a major cause of liver disease and is thus an important public health problem. Although some strains (genotypes) of the hepatitis C virus are highly responsive to treatment with a combination of peginterferon and ribavirin, the most common form of the virus (genotype 1) is relatively resistant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Peginterferon 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
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Jul 2011
- 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
- Age > 18 years
- Serum Hepatitis C RNA > 10,000IU/mL
- Hepatitis C virus genotype 1
- IL28B polymorphism
Who cannot join
- Previous treatment for chronic Hepatitis C
- clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml
- HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease
- Contraindications to PR-based treatment:
- uncontrolled psychiatric illness
- active substance dependency
Show all 18Show fewer
- Known autoimmune disorder
- Untreated thyroid disease
- Uncontrolled seizure disorder
- Pregnancy, lactation or inability to maintain contraception
- Chronic kidney disease w/ estimated GFR< 60
- ANC<1.5/nl, Hb<12g/dl, or platelets<75/nl
- Clinical or biochemical evidence of decompensated liver disease including:
- History of encephalopathy, ascites, or variceal bleeding OR
- Bilirubin > 3g/dl or INR > 1.5
- Life threatening disorder with expected median survival less than 5 years
- Inability to comply with drug regimens or testing schedule required for study
- Lack of insurance coverage for any of the study medications
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University School of Medicine
Atlanta, Georgia, 30030
Fletcher Allen Health Care
Burlington, Vermont, 05401
About this study
Official title: A Randomized Trial of Telaprevir, Peginterferon, and Ribavirin Versus Peginterferon and Ribavirin for Treatment of Genotype 1 Hepatitis C Virus With Host Interleukin 28B CC Polymorphism
Chronic hepatitis C is a major cause of liver disease and is thus an important public health problem. Although some strains (genotypes) of the hepatitis C virus are highly responsive to treatment with a combination of peginterferon and ribavirin, the most common form of the virus (genotype 1) is relatively resistant to this treatment. Recently, telaprevir has been approved by the Food and Drug Administration to be given in combination with peginterferon and ribavirin. This 3-drug combination boosts the remission rate for genotype 1 hepatitis C to that seen with other more responsive hepatitis C genotypes treated with only peginterferon and ribavirin. However, telaprevir has additional side affects such as rash and anemia that may limit its usefulness. Intriguingly, about one third of patients infected with genotype 1 hepatitis C, who have a specific variation (polymorphism) in the DNA sequence (CC) near an immune response gene (IL28B), in fact are highly responsive to 2-drug treatment with peginterferon and ribavirin. This raises the possibility that individuals who have the IL28B CC polymorphism may not need to be treated with the addition of telaprevir and could therefore be spared unnecessary side effects. Thus, the purpose of this study is to determine among genotype 1 hepatitis C patients with the IL28B CC polymorphism the success rate and side effects of 3-drug treatment compared with 2-drug treatment.
In this study, patients with genotype 1 chronic hepatitis C who have the IL28B CC polymorphism will be randomly assigned to be treated with telaprevir, peginterferon, and ribavirin or with only peginterferon with ribavirin. These medications and the procedures involved, including patient history, physical examination, and obtaining small volume blood specimens (less than 4 teaspoons) for laboratory testing, are within the scope of standard management of hepatitis C treatment. All patients will be monitored during treatment with periodic blood testing (weeks 2, 4, and every 4 weeks thereafter while on treatment, and 24 weeks after stopping treatment) and office visits (weeks 5, 12, 25, 49 while on treatment and 25 weeks after stopping treatment). The success of treatment will be judged by the presence or absence of detectable virus in blood, as measured by a sensitive diagnostic test (PCR). The data to be generated will include measurement by PCR of hepatitis C viral loads before, during, and after treatment, as well as reporting of adverse drug effects.
Read the detailed description
Chronic infection with the hepatitis C virus (HCV), which affects 1-2% of adults in the United States, is a major risk factor for liver failure due to cirrhosis and/or hepatocellular carcinoma (Davis 2010). Epidemiological information suggests that the frequency of these HCV-related sequelae is likely to continue to increase over the next 10-15 years unless effective and well-tolerated treatments become available. Development of improved antiviral therapy is thus an important public health priority.
Until recently, the most effective treatment for chronic HCV infection has been a combination of peginterferon and ribavirin, given for up to 48 weeks. With this regimen, the sustained virological response (SVR), defined as undetectable HCV RNA 24 weeks after completion of antiviral treatment, is approximately 50-60% (Hoofnagle 2006). Not all patients are able to complete therapy however; up to 10% will discontinue this prematurely as a result of intolerable side effects, predominantly depression and/or fatigue (Seeff 2010). The major determinants of responsiveness to antiviral therapy are viral genotype and selected host characteristics. Hepatitis C genotype 1 (HCV-1), which accounts for approximately 70% of chronic infections in North America, and is relatively resistant to treatment with peginterferon and ribavirin. SVR with treatment for HCV-1 is approximately 40% (Hoofnagle 2006). That said, among HCV-1-infected individuals, there is diversity in SVR, which is correlated with a dinucleotide polymorphism at a locus upstream of the interleukin 28B (IL28B) gene. Specifically, with 48 weeks of peginterferon and ribavirin therapy, 70% of individuals with the IL28B CC polymorphism achieve SVR, compared with only 30% of individuals with other IL28B polymorphisms (Thompson 2010).
New treatments for chronic HCV-1 infection are now available. In May 2011, the Food and Drug Administration (FDA) approved telaprevir, an orally available small molecule inhibitor of the HCV-1 protease, for treatment of chronic HCV-1, to be given in combination with peginterferon and ribavirin. In HCV-1-infected patients, this three-drug regimen has been shown to confer an SVR of 75% (Jacobson 2011). However, this regimen appears to be associated with up to a nearly 1.5-fold increase in premature drug discontinuation, in comparison with a regimen of peginterferon, and ribavirin alone, largely influenced by the development of telaprevir-associated rash. Given the high responsiveness to conventional peginterferon and ribavirin among HCV-1-infected individuals with the IL28B CC polymorphism, we hypothesize SVR will not be enhanced in such individuals by the addition of telaprevir to peginterferon and ribavirin therapy. If this is correct, HCV-1-infected patients with the IL28B CC polymorphism can then be treated with comparable success with peginterferon and ribavirin alone and will therefore be spared telaprevir-associated adverse affects.
The proposed study, which is a prospective randomized open label trial (in HCV-1-infected subjects with the IL28B CC polymorphism) of treatment with telaprevir (T), peginterferon (P), and ribavirin (R) versus PR alone, will test the working hypothesis. The study design takes advantage of the concept of response-guided treatment, a strategy in which the duration of antiviral treatment is based upon the presence or absence of a rapid virological response (RVR), defined as loss of detectable serum HCV RNA within the first 4 weeks of therapy. In particular, it has been shown that HCV-1 patients who achieve RVR (and maintain undetectable HCV RNA at 12 weeks (defined as eRVR), with either PR-containing or TPR-containing regimens have comparable SVR with 24 weeks, compared with 48 weeks, of total treatment (Mangia 2008, Jacobson 2011).
- Conditions
- Hepatitis C
- Being tested
- Peginterferon alfa-2a, Ribavirin, telaprevir
- Keywords
- genotype 1, IL28B CC polymorphism, telaprevir, peginterferon, ribavirin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2aDrug
180ug subcutaneously, weekly
RibavirinDrug
Administered orally twice a day as follows:
weight < 75kg - 1000mg weight ≥ 75kg - 1200mg
telaprevirDrug
750mg every 8 hours, orally
| Study group | Role | What they receive |
|---|---|---|
| PR | Active comparator | Treatment with Peginterferon and Ribavirin for up to 48 weeks
Those who achieve eRVR will receive 24 weeks of treatment Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin |
| TPR | Active comparator | Treatment with Telaprevir, Peginterferon and Ribavirin. Patients will receive all 3 drugs for 12 weeks then switch to Peginterferon and Ribavirin for 36 weeks
Those who achieve eRVR will receive 12 weeks of treatment with all 3 drugs and then 12 weeks of treatment with the 2 drugs. Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin; Drug: telaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response among subjects receiving a three drug versus two drug regimen of treatment
Sustained virological response is defined as undetectable hepatitis C virus RNA in the blood at 24 weeks after the completion of antiviral treatment. This will be measured by PCR to determine the hepatitis C viral load in blood at the indicated time point.
Measured: 24 weeks after completion of treatment
Secondary outcomes (1)
Extended rapid virological response in patients receiving three drug versus two drug regimen
Extended rapid virological response (eRVR) is defined as undetectable hepatitis C virus RNA in the blood at 4 and 12 weeks of treatment. This will be measured by PCR to measure viral load at the indicated time points.
Measured: weeks 4 and 12 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Lidofsky, University of Vermont
- Investigators
- Steven Lidofsky, MD, Principal investigator, University of Vermont & Fletcher Allen Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415141
- Sponsor's protocol ID
- M11-219
- Status last verified
- May 2017
- First submitted
- 1 Aug 2011
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010 Feb;138(2):513-21, 521.e1-6. doi: 10.1053/j.gastro.2009.09.067. Epub 2009 Oct 25.
PubMed 19861128Hoofnagle JH, Seeff LB. Peginterferon and ribavirin for chronic hepatitis C. N Engl J Med. 2006 Dec 7;355(23):2444-51. doi: 10.1056/NEJMct061675. No abstract available.
PubMed 17151366Mangia A, Minerva N, Bacca D, Cozzolongo R, Ricci GL, Carretta V, Vinelli F, Scotto G, Montalto G, Romano M, Cristofaro G, Mottola L, Spirito F, Andriulli A. Individualized treatment duration for hepatitis C genotype 1 patients: A randomized controlled trial. Hepatology. 2008 Jan;47(1):43-50. doi: 10.1002/hep.22061.
PubMed 18069698Seeff LB, Ghany MG. Management of untreated and nonresponder patients with chronic hepatitis C. Semin Liver Dis. 2010 Nov;30(4):348-60. doi: 10.1055/s-0030-1267536. Epub 2010 Oct 19.
PubMed 20960375Thompson AJ, Muir AJ, Sulkowski MS, Ge D, Fellay J, Shianna KV, Urban T, Afdhal NH, Jacobson IM, Esteban R, Poordad F, Lawitz EJ, McCone J, Shiffman ML, Galler GW, Lee WM, Reindollar R, King JW, Kwo PY, Ghalib RH, Freilich B, Nyberg LM, Zeuzem S, Poynard T, Vock DM, Pieper KS, Patel K, Tillmann HL, Noviello S, Koury K, Pedicone LD, Brass CA, Albrecht JK, Goldstein DB, McHutchison JG. Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in genotype 1 hepatitis C virus. Gastroenterology. 2010 Jul;139(1):120-9.e18. doi: 10.1053/j.gastro.2010.04.013. Epub 2010 Apr 24.
PubMed 20399780Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912.
PubMed 21696307
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Telaprevir, Peginterferon, and Ribavirin Versus Peginterferon and Ribavirin for Treatment of Genotype 1 Hepatitis C Virus With Host Interleukin 28B CC Polymorphism
- ClinicalTrials.gov ID
- NCT01415141
- Acronym / sponsor ID
- M11-219
- Conditions
- Hepatitis C
- Keywords
- genotype 1, IL28B CC polymorphism, telaprevir, peginterferon, ribavirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Jul 2011 (actual)
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 11 Aug 2011 (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.
Chronic hepatitis C is a major cause of liver disease and is thus an important public health problem. Although some strains (genotypes) of the hepatitis C virus are highly responsive to treatment with a combination of peginterferon and ribavirin, the most common form of the virus (genotype 1) is relatively resistant to this treatment. Recently, telaprevir has been approved by the Food and Drug Administration to be given in combination with peginterferon and ribavirin. This 3-drug combination boosts the remission rate for genotype 1 hepatitis C to that seen with other more responsive hepatitis C genotypes treated with only peginterferon and ribavirin. However, telaprevir has additional side affects such as rash and anemia that may limit its usefulness. Intriguingly, about one third of patients infected with genotype 1 hepatitis C, who have a specific variation (polymorphism) in the DNA sequence (CC) near an immune response gene (IL28B), in fact are highly responsive to 2-drug treatment with peginterferon and ribavirin. This raises the possibility that individuals who have the IL28B CC polymorphism may not need to be treated with the addition of telaprevir and could therefore be spared unnecessary side effects. Thus, the purpose of this study is to determine among genotype 1 hepatitis C patients with the IL28B CC polymorphism the success rate and side effects of 3-drug treatment compared with 2-drug treatment.
In this study, patients with genotype 1 chronic hepatitis C who have the IL28B CC polymorphism will be randomly assigned to be treated with telaprevir, peginterferon, and ribavirin or with only peginterferon with ribavirin. These medications and the procedures involved, including patient history, physical examination, and obtaining small volume blood specimens (less than 4 teaspoons) for laboratory testing, are within the scope of standard management of hepatitis C treatment. All patients will be monitored during treatment with periodic blood testing (weeks 2, 4, and every 4 weeks thereafter while on treatment, and 24 weeks after stopping treatment) and office visits (weeks 5, 12, 25, 49 while on treatment and 25 weeks after stopping treatment). The success of treatment will be judged by the presence or absence of detectable virus in blood, as measured by a sensitive diagnostic test (PCR). The data to be generated will include measurement by PCR of hepatitis C viral loads before, during, and after treatment, as well as reporting of adverse drug effects.
Detailed description
Chronic infection with the hepatitis C virus (HCV), which affects 1-2% of adults in the United States, is a major risk factor for liver failure due to cirrhosis and/or hepatocellular carcinoma (Davis 2010). Epidemiological information suggests that the frequency of these HCV-related sequelae is likely to continue to increase over the next 10-15 years unless effective and well-tolerated treatments become available. Development of improved antiviral therapy is thus an important public health priority.
Until recently, the most effective treatment for chronic HCV infection has been a combination of peginterferon and ribavirin, given for up to 48 weeks. With this regimen, the sustained virological response (SVR), defined as undetectable HCV RNA 24 weeks after completion of antiviral treatment, is approximately 50-60% (Hoofnagle 2006). Not all patients are able to complete therapy however; up to 10% will discontinue this prematurely as a result of intolerable side effects, predominantly depression and/or fatigue (Seeff 2010). The major determinants of responsiveness to antiviral therapy are viral genotype and selected host characteristics. Hepatitis C genotype 1 (HCV-1), which accounts for approximately 70% of chronic infections in North America, and is relatively resistant to treatment with peginterferon and ribavirin. SVR with treatment for HCV-1 is approximately 40% (Hoofnagle 2006). That said, among HCV-1-infected individuals, there is diversity in SVR, which is correlated with a dinucleotide polymorphism at a locus upstream of the interleukin 28B (IL28B) gene. Specifically, with 48 weeks of peginterferon and ribavirin therapy, 70% of individuals with the IL28B CC polymorphism achieve SVR, compared with only 30% of individuals with other IL28B polymorphisms (Thompson 2010).
New treatments for chronic HCV-1 infection are now available. In May 2011, the Food and Drug Administration (FDA) approved telaprevir, an orally available small molecule inhibitor of the HCV-1 protease, for treatment of chronic HCV-1, to be given in combination with peginterferon and ribavirin. In HCV-1-infected patients, this three-drug regimen has been shown to confer an SVR of 75% (Jacobson 2011). However, this regimen appears to be associated with up to a nearly 1.5-fold increase in premature drug discontinuation, in comparison with a regimen of peginterferon, and ribavirin alone, largely influenced by the development of telaprevir-associated rash. Given the high responsiveness to conventional peginterferon and ribavirin among HCV-1-infected individuals with the IL28B CC polymorphism, we hypothesize SVR will not be enhanced in such individuals by the addition of telaprevir to peginterferon and ribavirin therapy. If this is correct, HCV-1-infected patients with the IL28B CC polymorphism can then be treated with comparable success with peginterferon and ribavirin alone and will therefore be spared telaprevir-associated adverse affects.
The proposed study, which is a prospective randomized open label trial (in HCV-1-infected subjects with the IL28B CC polymorphism) of treatment with telaprevir (T), peginterferon (P), and ribavirin (R) versus PR alone, will test the working hypothesis. The study design takes advantage of the concept of response-guided treatment, a strategy in which the duration of antiviral treatment is based upon the presence or absence of a rapid virological response (RVR), defined as loss of detectable serum HCV RNA within the first 4 weeks of therapy. In particular, it has been shown that HCV-1 patients who achieve RVR (and maintain undetectable HCV RNA at 12 weeks (defined as eRVR), with either PR-containing or TPR-containing regimens have comparable SVR with 24 weeks, compared with 48 weeks, of total treatment (Mangia 2008, Jacobson 2011).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PR | Active comparator | Drug: Peginterferon alfa-2a, Drug: RibavirinTreatment with Peginterferon and Ribavirin for up to 48 weeks Those who achieve eRVR will receive 24 weeks of treatment |
| TPR | Active comparator | Drug: Peginterferon alfa-2a, Drug: Ribavirin, Drug: telaprevirTreatment with Telaprevir, Peginterferon and Ribavirin. Patients will receive all 3 drugs for 12 weeks then switch to Peginterferon and Ribavirin for 36 weeks Those who achieve eRVR will receive 12 weeks of treatment with all 3 drugs and then 12 weeks of treatment with the 2 drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Serum Hepatitis C RNA > 10,000IU/mL
- Hepatitis C virus genotype 1
- IL28B polymorphism
Key exclusion criteria (18 listed)
- Previous treatment for chronic Hepatitis C
- clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml
- HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease
- Contraindications to PR-based treatment:
- Clinical or biochemical evidence of decompensated liver disease including:
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 alfa-2a180ug subcutaneously, weekly | Drug | PR, TPR |
| RibavirinAdministered orally twice a day as follows: weight < 75kg - 1000mg weight ≥ 75kg - 1200mg | Drug | PR, TPR |
| telaprevir750mg every 8 hours, orally | Drug | TPR |
Primary outcome
Sustained virological response among subjects receiving a three drug versus two drug regimen of treatment
Time frame: 24 weeks after completion of treatment
Sustained virological response is defined as undetectable hepatitis C virus RNA in the blood at 24 weeks after the completion of antiviral treatment. This will be measured by PCR to determine the hepatitis C viral load in blood at the indicated time point.
1 secondary outcome
Extended rapid virological response in patients receiving three drug versus two drug regimen
Time frame: weeks 4 and 12 of treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Background: PubMed 19861128Davis GL, Alter MJ, El-Serag H, Poynard T, Jennings LW. Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression. Gastroenterology. 2010 Feb;138(2):513-21, 521.e1-6. doi: 10.1053/j.gastro.2009.09.067. Epub 2009 Oct 25.
- Background: PubMed 17151366Hoofnagle JH, Seeff LB. Peginterferon and ribavirin for chronic hepatitis C. N Engl J Med. 2006 Dec 7;355(23):2444-51. doi: 10.1056/NEJMct061675. No abstract available.
- Background: PubMed 18069698Mangia A, Minerva N, Bacca D, Cozzolongo R, Ricci GL, Carretta V, Vinelli F, Scotto G, Montalto G, Romano M, Cristofaro G, Mottola L, Spirito F, Andriulli A. Individualized treatment duration for hepatitis C genotype 1 patients: A randomized controlled trial. Hepatology. 2008 Jan;47(1):43-50. doi: 10.1002/hep.22061.
- Background: PubMed 20960375Seeff LB, Ghany MG. Management of untreated and nonresponder patients with chronic hepatitis C. Semin Liver Dis. 2010 Nov;30(4):348-60. doi: 10.1055/s-0030-1267536. Epub 2010 Oct 19.
- Background: PubMed 20399780Thompson AJ, Muir AJ, Sulkowski MS, Ge D, Fellay J, Shianna KV, Urban T, Afdhal NH, Jacobson IM, Esteban R, Poordad F, Lawitz EJ, McCone J, Shiffman ML, Galler GW, Lee WM, Reindollar R, King JW, Kwo PY, Ghalib RH, Freilich B, Nyberg LM, Zeuzem S, Poynard T, Vock DM, Pieper KS, Patel K, Tillmann HL, Noviello S, Koury K, Pedicone LD, Brass CA, Albrecht JK, Goldstein DB, McHutchison JG. Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in genotype 1 hepatitis C virus. Gastroenterology. 2010 Jul;139(1):120-9.e18. doi: 10.1053/j.gastro.2010.04.013. Epub 2010 Apr 24.
- Background: PubMed 21696307Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912.
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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.
Steven Lidofsky, MD principal investigator
University of Vermont & Fletcher Allen Health Care
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peginterferon alfa-2a, Ribavirin and telaprevir in people with Hepatitis C, run by University of Vermont at 2 sites 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 4 inclusion and 18 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: withdrawn, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Sustained virological response among subjects receiving a three drug versus two drug regimen of treatment (time frame: 24 weeks after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01415141, which also lists 6 linked publications.
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 9 May 2017.