Hepatitis CPhase 4TIG3NCT02087111
Telaprevir in Genotype 3 HCV
A Phase 4 study testing Telaprevir, 40 Kd Pegylated interferon alfa 2a and Ribavirin in people with Hepatitis C, run by Queen Mary University of London at 4 sites in United Kingdom.
Trial summary
Patients with genotype 3 hepatitis C who have advanced liver disease (cirrhosis) have a very high chance of developing fatal complications of their disease unless they receive effective treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Telaprevir, 40 Kd Pegylated interferon alfa 2a and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- Apr 2014to 1 Nov 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years of age and ≤ 70 years old
- Advanced fibrosis - defined as a liver biopsy within 2 years showing an Ishak fibrosis score of >4 OR radiological evidence of cirrhosis (ultrasound scan or fibroscan reading >10.6)
- Previous therapy with pegylated interferon and ribavirin for at least 24 weeks with undetectable HCV RNA at the end of therapy and detectable HCV RNA six months after treatment cessation
- Chronic genotype 3 HCV infection, RNA positivity with genotype 3 infection confirmed at a local laboratory.
- HBsAg negative and no clinical evidence of co-infection with HIV
- Platelet count >50,000 cells/mm3 (support with eltrombopag is permitted) Neutrophil count > 600 cells/mm3
- All female patients of childbearing potential and all males with female partners of childbearing potential must be prepared to use two forms of effective contraception* (combined) during treatment and 6 months after treatment end
- Able and willing to give informed consent and able to comply with study requirements
Who cannot join
- Evidence of other cause of significant liver disease - serum ferritin > 1000, biochemical evidence of Wilson's disease, autoantibody titres in excess of 1:160
- Poorly controlled diabetes that, in the investigators opinion, precludes therapy
- Severe retinopathy that, in the opinion of the investigator, precludes therapy
- Evidence of ascites seen on previous liver ultrasound
- Haemoglobin concentration <11 g/dL in females or <12 g/dL in males or any patient with an increased risk for anaemia (e.g., thalassemia, sickle cell anaemia, spherocytosis, history of gastrointestinal bleeding) or for whom anaemia would be medically problematic
- Albumin levels <35 G/L
Show all 17Show fewer
- Females who are pregnant or breast-feeding
- History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease within the last 2 years
- History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis (defined as affecting >10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected), rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management
- Other on-going serious medical condition in the opinion of the investigator that would prohibit treatment
- Poorly controlled thyroid dysfunction that, in the investigators opinion, precludes therapy
- History of major organ transplantation with an existing functional graft
- History of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous 6 months
- History or laboratory testing showing evidence of a haemoglobinopathy
- Concomitant administration with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These active substances include alfuzosin, amiodarone, bepridil, quinidine, astemizole, terfenadine, cisapride, pimozide, ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), lovastatin, simvastatin, atorvastatin, sildenafil or tadalafil (only when used for treatment of pulmonary arterial hypertension) and orally administered midazolam or triazolam.
- Concomitant administration with Class Ia or III antiarrhythmics, except for intravenous lidocaine (see section 4.5).
- Concomitant administration of INCIVO with active substances that strongly induce CYP3A e.g. rifampicin, St John's wort (Hypericum perforatum), carbamazepine, phenytoin and phenobarbital and thus may lead to lower exposure and loss of efficacy of INCIVO.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, BD9 6RJ
Barts Health NHS Trust
London, E1 1BB
Ste Georges Healthcare NHS Trust
London, SW17 0QT
Nottingham University Hospitals Trust
Nottingham, NG7 2UH
About this study
Official title: Telaprevir in Patients With Genotype 3 HCV: Pilot Clinical Study to Evaluate Efficacy and Predictability of Therapy in Patients Who Have Failed to Respond to Pegylated Interferon and Ribavirin
Patients with genotype 3 hepatitis C who have advanced liver disease (cirrhosis) have a very high chance of developing fatal complications of their disease unless they receive effective treatment. Unfortunately the best drugs that are currently available to treat genotype 3 hepatitis C (pegylated interferon and ribavirin) only work in about 50% of patients with advanced liver disease and therefore a large number of patients who have failed treatment are waiting for new, better drugs. Currently there are no treatments available for these patients. Telaprevir is a new drug that is licensed to treat genotype 1 hepatitis C and which works very well in these patients. In patients with genotype 3 hepatitis C small scale trials and laboratory studies show that some patients do respond quite well and others respond a little bit when given telaprevir. In patients who have exhausted all other treatment options the investigators speculate that telaprevir treatment may help some patients by clearing their infection. The purpose of this study is to see if telaprevir can help these patients and to determine if the investigators can predict in advance which people can be helped.
Read the detailed description
This is an open label, 'proof of concept' study to examine the hypothesis that telaprevir is effective in patients with genotype 3 HCV and cirrhosis who have failed to respond to pegylated interferon and ribavirin. The study will examine the hypothesis that pretreatment viral testing will identify patients who will respond to antiviral therapy with telaprevir.
Patients who are eligible for the study will be asked if they are willing to participate and if they wish to join the study they will be asked to sign the informed consent form. After signing the consent form patients will attend the hospital and be screened for the trial. This will involve a physical examination and blood samples will be taken. Patients will be provided with an injection of pegylated interferon to be self administered every week along with ribavirin tablets (4 tablets a day) and telaprevir tablets (6 tablets a day). Patients will be taught how to self administer the pegylated interferon medication. Patients will reattend every week for the next 4 weeks. At each visit they will be asked questions about the medication that they are taking, questions about how they are feeling and any side effects and 30 mls of blood will be taken.
At the fourth visit (week 4) the amount of circulating HCV will be assessed using a standard laboratory assay and patients will be telephoned within 1 week of the visit. If the viral load is more than 1000 IU/ml therapy will be stopped as the chance of the patient responding to therapy is very low (in the clinical studies with genotype 1 HCV no patients responded who had a viral load of >1000 IU/ml at week 4). If patients are responding to therapy they will be asked to continue with medication and seen again 4 weeks later (8 weeks after initiating therapy).
At week 8 of therapy patients will be asked questions about the medication that they are taking, questions about how they are feeling and any side effects and blood will be taken. Again the viral load will be tested and if the viral load is more than 1000 IU/ml therapy or the viral load has not decreased by 3 logs from baseline therapy will be stopped as the chance of the patient responding to therapy is very low. If patients are responding to therapy they will be asked to continue with medication and seen again 4 weeks later (12 weeks after initiating therapy).
At week 12 of therapy patients will be asked questions about the medication that they are taking, questions about how they are feeling and any side effects and blood will be taken. At this visit they will be told to stop taking the telaprevir tablets as the recommended duration of telaprevir therapy is 12 weeks. Patients will continue to take pegylated interferon and ribavirin.
Patients will be seen again every 4 weeks for another 8 weeks and they will continue to take pegylated interferon injections every week and 4 ribavirin tablets every day. At each clinic visit they will be asked questions about the medication that they are taking, questions about how they are feeling and any side effects and blood will be taken.
After 24 weeks of therapy (i.e. 4 weeks after the last visit) patients will be seen again and asked questions about the medication that they are taking, questions about how they are feeling and any side effects and blood will be taken. At this visit they will be told to stop taking all medication. They will be asked to return in 12 weeks.
12 weeks after stopping therapy patients will return to the clinic and asked questions about how they are feeling and any side effects and blood will be taken. They will be asked to return in 12 weeks.
24 weeks after stopping therapy patients will return to the clinic and asked questions about how they are feeling and any side effects and blood will be taken. The study will then end and they will return to routine clinical follow up where they will be seen by their clinical team.
- Conditions
- Hepatitis C
- Being tested
- Telaprevir, 40 Kd Pegylated interferon alfa 2a, Ribavirin
- Keywords
- Telaprevir, Genotype 3 HCV
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelaprevirDrug
Also called INCIVO
375 mg film coated tablets
40 Kd Pegylated interferon alfa 2aDrug
Also called Pegasys
180 µg in pre-filled syringe for sub-cutaneous injection
RibavirinDrug
Also called Copegus
200 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All patients who are fulfil the entry criteria are treated for 24 weeks with 40 Kd Pegylated interferon alfa 2a, Ribavirin and 12 weeks with telaprevir. Receives: Drug: Telaprevir; Drug: 40 Kd Pegylated interferon alfa 2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response (SVR) 12 weeks after end of treatment (SVR12)
To determine whether patients with genotype 3 HCV and cirrhosis who have relapsed following therapy with PegIFN and RBV will achieve a sustained virological response (SVR) if treated with telaprevir, PegIFN and RBV
Measured: Week 36
Secondary outcomes (3)
Response rate prediction
The proportion of patients who are phenotypically poorly responsive to telaprevir (defined as virus with a poor response to telaprevir in vitro i.e. an IC50 of <0.1microMol in an in vitro assay) who achieve early and late virological clearance.
Measured: By week 12
Sustained virological response 24 weeks after end of treatment.
The proportion of patients with a sustained virological response 24 weeks after the last dose of PegIFN and RBV (SVR24). SVR 24 is defined as undetectable HCV RNA on a blood sample taken between 24 and 30 weeks after the final dose of PegIFN and ribavirin measured using a sensitive, validated polymerase chain reaction (PCR) assay with a lower limit of quantification of at least 30IU/ml.
Measured: week 48
Treatment Success
The proportion of patients who have undetectable HCV RNA (measured using a sensitive, validated polymerase chain reaction (PCR) assay with a lower limit of quantification of at least 30IU/ml) after 1,2,3 and 4 weeks of therapy with PegIFN, RBV and telaprevir.
Measured: After week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startApr 2014
- Primary completion1 Nov 2016
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd., Barts & The London NHS Trust, St George's Healthcare NHS Trust, Bradford Teaching Hospitals NHS Foundation Trust, Nottingham University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Graham R Foster, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087111
- Sponsor's protocol ID
- 9132
- Other IDs
- 2013-003729-27, 13/LO/1473
- Acronym
- TIG3
- Status last verified
- Jul 2014
- First submitted
- 12 Mar 2014
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shoeb D, Rowe IA, Freshwater D, Mutimer D, Brown A, Moreea S, Sood R, Marley R, Sabin CA, Foster GR. Response to antiviral therapy in patients with genotype 3 chronic hepatitis C: fibrosis but not race encourages relapse. Eur J Gastroenterol Hepatol. 2011 Sep;23(9):747-53. doi: 10.1097/MEG.0b013e3283488aba.
PubMed 21691208Alazawi W, Cunningham M, Dearden J, Foster GR. Systematic review: outcome of compensated cirrhosis due to chronic hepatitis C infection. Aliment Pharmacol Ther. 2010 Aug;32(3):344-55. doi: 10.1111/j.1365-2036.2010.04370.x. Epub 2010 May 22.
PubMed 20497143Jacobson 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 21696307Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.
PubMed 21696308Foster GR, Hezode C, Bronowicki JP, Carosi G, Weiland O, Verlinden L, van Heeswijk R, van Baelen B, Picchio G, Beumont M. Telaprevir alone or with peginterferon and ribavirin reduces HCV RNA in patients with chronic genotype 2 but not genotype 3 infections. Gastroenterology. 2011 Sep;141(3):881-889.e1. doi: 10.1053/j.gastro.2011.05.046. Epub 2011 May 31.
PubMed 21699786
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telaprevir in Patients With Genotype 3 HCV: Pilot Clinical Study to Evaluate Efficacy and Predictability of Therapy in Patients Who Have Failed to Respond to Pegylated Interferon and Ribavirin
- ClinicalTrials.gov ID
- NCT02087111
- Acronym / sponsor ID
- TIG3 / 9132
- Conditions
- Hepatitis C
- Keywords
- Telaprevir, Genotype 3 HCV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd., Barts & The London NHS Trust, St George's Healthcare NHS Trust, Bradford Teaching Hospitals NHS Foundation Trust, Nottingham University Hospitals NHS Trust
- Study start
- Apr 2014
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 14 Mar 2014 (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.
Patients with genotype 3 hepatitis C who have advanced liver disease (cirrhosis) have a very high chance of developing fatal complications of their disease unless they receive effective treatment. Unfortunately the best drugs that are currently available to treat genotype 3 hepatitis C (pegylated interferon and ribavirin) only work in about 50% of patients with advanced liver disease and therefore a large number of patients who have failed treatment are waiting for new, better drugs. Currently there are no treatments available for these patients. Telaprevir is a new drug that is licensed to treat genotype 1 hepatitis C and which works very well in these patients. In patients with genotype 3 hepatitis C small scale trials and laboratory studies show that some patients do respond quite well and others respond a little bit when given telaprevir. In patients who have exhausted all other treatment options the investigators speculate that telaprevir treatment may help some patients by clearing their infection. The purpose of this study is to see if telaprevir can help these patients and to determine if the investigators can predict in advance which people can be helped.
Detailed description
This is an open label, 'proof of concept' study to examine the hypothesis that telaprevir is effective in patients with genotype 3 HCV and cirrhosis who have failed to respond to pegylated interferon and ribavirin. The study will examine the hypothesis that pretreatment viral testing will identify patients who will respond to antiviral therapy with telaprevir.
Patients who are eligible for the study will be asked if they are willing to participate and if they wish to join the study they will be asked to sign the informed consent form. After signing the consent form patients will attend the hospital and be screened for the trial. This will involve a physical examination and blood samples will be taken. Patients will be provided with an injection of pegylated interferon to be self administered every week along with ribavirin tablets (4 tablets a day) and telaprevir tablets (6 tablets a day). Patients will be taught how to self administer the pegylated interferon medication. Patients will reattend every week for the next 4 weeks. At each visit they will be asked questions about the medication that they are taking, questions about how they are feeling and any side effects and 30 mls of blood will be taken.
At the fourth visit (week 4) the amount of circulating HCV will be assessed using a standard laboratory assay and patients will be telephoned within 1 week of the visit. If the viral load is more than 1000 IU/ml therapy will be stopped as the chance of the patient responding to therapy is very low (in the clinical studies with genotype 1 HCV no patients responded who had a viral load of >1000 IU/ml at week 4). If patients are responding to therapy they will be asked to continue with medication and seen again 4 weeks later (8 weeks after initiating therapy).
At week 8 of therapy patients will be asked questions about the medication that they are taking, questions about how they are feeling and any side effects and blood will be taken. Again the viral load will be tested and if the viral load is more than 1000 IU/ml therapy or the viral load has not decreased by 3 logs from baseline therapy will be stopped as the chance of the patient responding to therapy is very low. If patients are responding to therapy they will be asked to continue with medication and seen again 4 weeks later (12 weeks after initiating therapy).
At week 12 of therapy patients will be asked questions about the medication that they are taking, questions about how they are feeling and any side effects and blood will be taken. At this visit they will be told to stop taking the telaprevir tablets as the recommended duration of telaprevir therapy is 12 weeks. Patients will continue to take pegylated interferon and ribavirin.
Patients will be seen again every 4 weeks for another 8 weeks and they will continue to take pegylated interferon injections every week and 4 ribavirin tablets every day. At each clinic visit they will be asked questions about the medication that they are taking, questions about how they are feeling and any side effects and blood will be taken.
After 24 weeks of therapy (i.e. 4 weeks after the last visit) patients will be seen again and asked questions about the medication that they are taking, questions about how they are feeling and any side effects and blood will be taken. At this visit they will be told to stop taking all medication. They will be asked to return in 12 weeks.
12 weeks after stopping therapy patients will return to the clinic and asked questions about how they are feeling and any side effects and blood will be taken. They will be asked to return in 12 weeks.
24 weeks after stopping therapy patients will return to the clinic and asked questions about how they are feeling and any side effects and blood will be taken. The study will then end and they will return to routine clinical follow up where they will be seen by their clinical team.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Telaprevir, Drug: 40 Kd Pegylated interferon alfa 2a, Drug: RibavirinAll patients who are fulfil the entry criteria are treated for 24 weeks with 40 Kd Pegylated interferon alfa 2a, Ribavirin and 12 weeks with telaprevir. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years of age and ≤ 70 years old
- Advanced fibrosis - defined as a liver biopsy within 2 years showing an Ishak fibrosis score of >4 OR radiological evidence of cirrhosis (ultrasound scan or fibroscan reading >10.6)
- Previous therapy with pegylated interferon and ribavirin for at least 24 weeks with undetectable HCV RNA at the end of therapy and detectable HCV RNA six months after treatment cessation
- Chronic genotype 3 HCV infection, RNA positivity with genotype 3 infection confirmed at a local laboratory.
- HBsAg negative and no clinical evidence of co-infection with HIV
Key exclusion criteria (17 listed)
- Evidence of other cause of significant liver disease - serum ferritin > 1000, biochemical evidence of Wilson's disease, autoantibody titres in excess of 1:160
- Poorly controlled diabetes that, in the investigators opinion, precludes therapy
- Severe retinopathy that, in the opinion of the investigator, precludes therapy
- Evidence of ascites seen on previous liver ultrasound
- Haemoglobin concentration <11 g/dL in females or <12 g/dL in males or any patient with an increased risk for anaemia (e.g., thalassemia, sickle cell anaemia, spherocytosis, history of gastrointestinal bleeding) or for whom anaemia would be medically problematic
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 |
|---|---|---|
| TelaprevirAlso: INCIVO375 mg film coated tablets | Drug | Treatment |
| 40 Kd Pegylated interferon alfa 2aAlso: Pegasys180 µg in pre-filled syringe for sub-cutaneous injection | Drug | Treatment |
| RibavirinAlso: Copegus200 mg tablets | Drug | Treatment |
Primary outcome
Sustained virological response (SVR) 12 weeks after end of treatment (SVR12)
Time frame: Week 36
To determine whether patients with genotype 3 HCV and cirrhosis who have relapsed following therapy with PegIFN and RBV will achieve a sustained virological response (SVR) if treated with telaprevir, PegIFN and RBV
3 secondary outcomes
Response rate prediction
Time frame: By week 12
Sustained virological response 24 weeks after end of treatment.
Time frame: week 48
Treatment Success
Time frame: After week 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Background: PubMed 21691208Shoeb D, Rowe IA, Freshwater D, Mutimer D, Brown A, Moreea S, Sood R, Marley R, Sabin CA, Foster GR. Response to antiviral therapy in patients with genotype 3 chronic hepatitis C: fibrosis but not race encourages relapse. Eur J Gastroenterol Hepatol. 2011 Sep;23(9):747-53. doi: 10.1097/MEG.0b013e3283488aba.
- Background: PubMed 20497143Alazawi W, Cunningham M, Dearden J, Foster GR. Systematic review: outcome of compensated cirrhosis due to chronic hepatitis C infection. Aliment Pharmacol Ther. 2010 Aug;32(3):344-55. doi: 10.1111/j.1365-2036.2010.04370.x. Epub 2010 May 22.
- 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.
- Background: PubMed 21696308Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, Focaccia R, Younossi Z, Foster GR, Horban A, Ferenci P, Nevens F, Mullhaupt B, Pockros P, Terg R, Shouval D, van Hoek B, Weiland O, Van Heeswijk R, De Meyer S, Luo D, Boogaerts G, Polo R, Picchio G, Beumont M; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med. 2011 Jun 23;364(25):2417-28. doi: 10.1056/NEJMoa1013086.
- Background: PubMed 21699786Foster GR, Hezode C, Bronowicki JP, Carosi G, Weiland O, Verlinden L, van Heeswijk R, van Baelen B, Picchio G, Beumont M. Telaprevir alone or with peginterferon and ribavirin reduces HCV RNA in patients with chronic genotype 2 but not genotype 3 infections. Gastroenterology. 2011 Sep;141(3):881-889.e1. doi: 10.1053/j.gastro.2011.05.046. Epub 2011 May 31.
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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.
Graham R Foster principal investigator
Queen Mary University of London
4 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 Telaprevir, 40 Kd Pegylated interferon alfa 2a and Ribavirin in people with Hepatitis C, run by Queen Mary University of London at 4 sites in United Kingdom.
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 8 inclusion and 17 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 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (SVR) 12 weeks after end of treatment (SVR12) (time frame: Week 36). 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 NCT02087111, which also lists 5 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 5 Jan 2023.