Chronic Hepatitis CPhase 3EXACT-R(3)NCT01095445
EXtended Therapy in Hepatitis C Genotype 3 Infected Patients
A Phase 3 study testing Peginterferon alfa-2b (Pegetron) plus ribavirin (Rebetol) in people with Chronic Hepatitis C, run by University Health Network, Toronto at 12 sites in Canada.
Trial summary
The purpose of this study is to evaluate the effect of 48 vs 24 weeks of treatment with Peginterferon alfa-2b plus weight-based ribavirin on Sustained Virologic Response (SVR) and relapse rates in patients infected with genotype 3 chronic hepatitis C (CHC) who do not achieve a Rapid Virologic Response (RVR) but attain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Peginterferon alfa-2b (Pegetron) plus ribavirin (Rebetol)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 12 sitesCanada
- Study dates
- Feb 2010to Jun 2011
- Phase
- Phase 3
- 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
- Infected with only genotype 3, hepatitis C
- Treatment naïve before current course of therapy
- A positive HCV RNA test result at Week 4 (no RVR)
- A negative HCV RNA test result at Week 12 (cEVR)
- A recent liver biopsy (within 3 years prior to study entry) is required. If the patient has either liver biopsy proven cirrhosis in the past or has splenomegaly with features of cirrhosis on ultrasound and/or thrombocytopenia (<150x109/ml) at any time in the past or has a Fibroscan reading of 10 or above or has a Fibrotest score of 0.75 or above (equivalent to F3 on the METAVIR scale), a biopsy will not be required. A copy of the latest report must be available.
Who cannot join
- Under age 18
- Co-infection with HIV or Hepatitis B or any other HCV genotype in addition to genotype 3
- Prior treatment for Hepatitis C aside from herbal remedies
- Evidence of decompensated liver disease, such as ascites, bleeding varices, hepatic encephalopathy or jaundice (conjugated hyperbilirubinemia)
- INR > 1.3 at baseline
- Platelet count <70 X 109/μl at baseline
Show all 12Show fewer
- Those subjects with diabetes and/or systemic hypertension will need to have ocular examinations (as per standard of care [SOC]) prior to treatment and will be excluded if they are found to have a diabetic retinopathy, optic nerve disorders, retinal hemorrhage or any other clinically significant abnormality
- Pre-existing psychiatric conditions including:
- Current moderate or severe depression despite appropriate therapy.
- Active suicidal ideation or previous attempt at suicide
- Patients with a history of severe psychiatric disorder (may be included if so desired by the investigator but pretreatment psychiatric evaluation is required (SOC)).
- Clinical diagnosis of current substance abuse: Alcohol (>40g/d), injection drugs, inhalational drugs (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over the counter drugs within one year of the screening visit.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Calgary Heart Centre
Calgary, Alberta, T2N 4Z6
Hys Med Centre
Edmonton, Alberta, T2N 4Z6
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
London Health Sciences Centre
London, Ontario, N6A 5A5
Dr. Dalia El-Ashry clinic
Mississauga, Ontario, L5B 2V2
Credit Valley Med Arts Centre
Mississauga, Ontario, L5M2V8
SMBD Jewish Gen Hosp
Montreal, Quebec, H3T 1E2
Toronto General Hospital - Dr. M. Sherman
Toronto, Ontario, M5G 2C4
Toronto Western Hospital - Liver Clinic
Toronto, Ontario, M5T 2S8
Liver and Intestinal Research Centre
Vancouver, British Columbia, V5Z 1H2
Dr. John D Farley Medical Office
Vancouver, British Columbia, V6A 4B6
Pacific Gastroenterology Assoc
Vancouver, British Columbia, V6Z 2K5
About this study
Official title: EXtended Therapy in Genotype 3 Infected Patients Who do Not AChieve a Treatment Response at Week 4 (RVR) But do Achieve a Complete Early Virologic Response (cEVR)
The purpose of this study is to evaluate the effect of 48 vs 24 weeks of treatment with Peginterferon alfa-2b plus weight-based ribavirin on Sustained Virologic Response (SVR) and relapse rates in patients infected with genotype 3 chronic hepatitis C (CHC) who do not achieve a Rapid Virologic Response (RVR) but attain a complete Early Virologic Response (cEVR).
Read the detailed description
This study plans to address the issue of whether increasing the duration of therapy from 24 weeks to 48 weeks with PegIFNα2b 1.5mg/kg/week and using weight-based ribavirin (15mg/kg) may reduce relapse rates and thereby increase SVR rates in patients infected with genotype 3 who fail to achieve an RVR but do achieve a complete cEVR defined as undetectable HCV RNA (ie. <50 or <15 IU/ml by 12 weeks). This study is necessary because although most patients with genotype 3 ultimately become HCV RNA undetectable during treatment, relapse after discontinuation of therapy remains a major cause of failure to achieve SVR. This is a very important issue given that to date none of the new small molecule drugs appear effective against genotype 3 meaning that at the present time patients with genotype 3 infection have no other options. Relapse is particularly common in patients with advanced liver disease but it has been shown that if SVR can be achieved in patients with advanced disease, the risk of liver failure is significantly reduced, as may be the risk of hepatocellular carcinoma (HCC). As a consequence the need for liver transplantation is diminished and survival is improved. Identifying strategies to reduce relapse and improve rates of SVR are therefore critical.
Certain individuals are at greater risk of infection with genotype 3. In the Western world, the main risk groups are current or former drug users (IDU) and immigrants raised in South Asia (India and Pakistan) where infection likely occurs early in childhood due to exposure to contaminated instruments, needles, etc.
A second potential benefit of achieving SVR is reduction in the rate of diabetes. Diabetes has been demonstrated to be more common in those infected with Hepatitis C than in the general population - this observation was made by examination of the NHANES population based database. The prelude to the development of Type 2 diabetes is insulin resistance. Insulin resistance (IR) is present in about one third of patients chronically infected with HCV - the rate being highest in those with cirrhosis and in those who are overweight or obese. Early data indicates that although the presence of insulin resistance impairs interferon responsiveness if SVR can be achieved, insulin resistance is lost. Studies of IR in individuals infected with genotype 3 HCV are lacking. Independent of HCV infection, being born South Asian is a risk factor for Type 2 diabetes.
The issue of insulin resistance and the effectiveness of antiviral therapy in chronic hepatitis C has been addressed exclusively in Caucasians infected with genotype 1. Recent data from Japan indicates that in patients with diabetes and hepatitis C successful eradication of HCV RNA may simultaneously prevent subsequent diabetes and presumably the systemic complications of this disease.
There is little data on the rate of RVR in the South Asian population as few therapeutic trials in patients with genotype 3 infections have been reported from Pakistan and India. Estimates can only be obtained from studies performed in Caucasians from Northern Europe and North America. In the trial by Shiffman the rate of RVR in those with genotype 3 infection was 62% and preliminary report from the trial of Albuferon in those with genotype 2 and 3 indicate RVR rates ranged from 44-60% in Asians -this figure included all Asians.
There are several reasons to specifically address ways to improve the outcome of antiviral therapy in patients infected with genotype 3 CHC. Firstly virtually all treatment studies report on a combined rate of SVR achieved in genotypes 2 and 3 even though the evidence has suggested that the response to therapy is different between these two genotypes. Within populations of patients with genotype 3 infection, there may be differences as well. South Asians are predominantly infected with genotype 3a, while injection drug users typically have genotype 3b infection. There are no formal trials published in the English literature of antiviral therapy in South Asians or comparing subtypes of genotype 3.
In patients infected with genotype 1 slow response to antiviral therapy i.e. lack of RVR, is associated with a significantly higher rate of relapse in those who go on to achieve undetectable HCV RNA at 12 weeks rather than at 4 weeks into treatment. Extending treatment for a further six months reduces this relapse rate considerably. By extending treatment in patients infected with genotype 3 who had previously relapsed following only 14 weeks of therapy to 24 weeks reduced relapse rates. Thus, it is anticipated that by extending treatment from 24 to 48 weeks in those who fail to achieve a RVR (i.e. slow responders) but who do achieve a complete EVR we hope to prevent relapse off treatment. A potential added benefit of achieving SVR in this patient population, many of whom are already at high risk of T2DM, is that it may reduce the virally mediated component of IR.
- Conditions
- Chronic Hepatitis C
- Being tested
- Peginterferon alfa-2b (Pegetron) plus ribavirin (Rebetol)
- Keywords
- hepatitis C, genotype 3, end of treatment response, relapse rate, rapid virologic response, complete early virologic response
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2b (Pegetron) plus ribavirin (Rebetol)Drug
Also called Pegetron, Rebetol
Dosage Form: Pegetron - powder for solution; Rebetol - capsules Strength: Pegetron Redipen - 120 mcg per pen; Rebetol - 200 mg Route of Administration: Pegetron - subcutaneous; Rebetol - oral
| Study group | Role | What they receive |
|---|---|---|
| Standard of care treatment | No intervention | Participants will be randomized to receive only the standard 24 weeks of therapy (Peginterferon alfa-2b plus ribavirin). |
| Extended therapy | Active comparator | Participants will be randomized to receive 24 weeks of therapy (Peginterferon alfa-2b plus ribavirin) in addition to their standard of care therapy. Receives: Drug: Peginterferon alfa-2b (Pegetron) plus ribavirin (Rebetol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of treatment response
Undetectable hepatitis C virus (HCV) RNA at 24 weeks following end of therapy
Measured: 24 weeks following end of therapy
Secondary outcomes (1)
Relapse rate
Undetectable HCV RNA at end of treatment but detectable HCV RNA at 24 weeks following end of therapy
Measured: 24 weeks following end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Unlikely to recruit the adequate number of patients within a reasonable timeline
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough
- Responsible party
- Sponsor
- Investigators
- E. Jenny Heathcote, MB,BS,MD,FRCP,FRCP(C), Principal investigator, University Health Network - Toronto Western Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095445
- Sponsor's protocol ID
- EXACT-R(3)
- Acronym
- EXACT-R(3)
- Status last verified
- Mar 2010
- First submitted
- 26 Mar 2010
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer H Jr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM; PEGASYS International Study Group. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004 Mar 2;140(5):346-55. doi: 10.7326/0003-4819-140-5-200403020-00010.
PubMed 14996676Zeuzem S, Hultcrantz R, Bourliere M, Goeser T, Marcellin P, Sanchez-Tapias J, Sarrazin C, Harvey J, Brass C, Albrecht J. Peginterferon alfa-2b plus ribavirin for treatment of chronic hepatitis C in previously untreated patients infected with HCV genotypes 2 or 3. J Hepatol. 2004 Jun;40(6):993-9. doi: 10.1016/j.jhep.2004.02.007.
PubMed 15158341Powis J, Peltekian KM, Lee SS, Sherman M, Bain VG, Cooper C, Krajden M, Deschenes M, Balshaw RF, Heathcote EJ, Yoshida EM; Canadian Pegasys Study Group. Exploring differences in response to treatment with peginterferon alpha 2a (40kD) and ribavirin in chronic hepatitis C between genotypes 2 and 3. J Viral Hepat. 2008 Jan;15(1):52-7. doi: 10.1111/j.1365-2893.2007.00889.x.
PubMed 18088245Dalgard O, Bjoro K, Hellum KB, Myrvang B, Ritland S, Skaug K, Raknerud N, Bell H. Treatment with pegylated interferon and ribavarin in HCV infection with genotype 2 or 3 for 14 weeks: a pilot study. Hepatology. 2004 Dec;40(6):1260-5. doi: 10.1002/hep.20467.
PubMed 15558712Lagging M, Langeland N, Pedersen C, Farkkila M, Buhl MR, Morch K, Dhillon AP, Alsio A, Hellstrand K, Westin J, Norkrans G; NORDynamIC Study Group. Randomized comparison of 12 or 24 weeks of peginterferon alpha-2a and ribavirin in chronic hepatitis C virus genotype 2/3 infection. Hepatology. 2008 Jun;47(6):1837-45. doi: 10.1002/hep.22253.
PubMed 18454508Mangia A, Santoro R, Minerva N, Ricci GL, Carretta V, Persico M, Vinelli F, Scotto G, Bacca D, Annese M, Romano M, Zechini F, Sogari F, Spirito F, Andriulli A. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2005 Jun 23;352(25):2609-17. doi: 10.1056/NEJMoa042608.
PubMed 15972867Dalgard O, Bjoro K, Ring-Larsen H, Bjornsson E, Holberg-Petersen M, Skovlund E, Reichard O, Myrvang B, Sundelof B, Ritland S, Hellum K, Fryden A, Florholmen J, Verbaan H; North-C Group. Pegylated interferon alfa and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3 and rapid virological response. Hepatology. 2008 Jan;47(1):35-42. doi: 10.1002/hep.21975.
PubMed 17975791Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34. doi: 10.1056/NEJMoa066403.
PubMed 17625124Bain VG, Kaita KD, Marotta P, Yoshida EM, Swain MG, Bailey RJ, Patel K, Cronin PW, Pulkstenis E, McHutchison JG, Subramanian GM. Safety and antiviral activity of albinterferon alfa-2b dosed every four weeks in genotype 2/3 chronic hepatitis C patients. Clin Gastroenterol Hepatol. 2008 Jun;6(6):701-6. doi: 10.1016/j.cgh.2008.02.056. Epub 2008 May 7.
PubMed 18467185Vigani AG, Pavan MH, Tozzo R, Goncales ES, Feltrin A, Fais VC, Lazarini MS, Goncales NS, Goncales FL Jr. Comparative study of patients with chronic hepatitis C virus infection due to genotypes 1 and 3 referred for treatment in southeast Brazil. BMC Infect Dis. 2008 Dec 4;8:164. doi: 10.1186/1471-2334-8-164.
PubMed 19055835Mangia A, Minerva N, Bacca D, Cozzolongo R, Agostinacchio E, Sogari F, Scotto G, Vinelli F, Ricci GL, Romano M, Carretta V, Petruzzellis D, Andriulli A. Determinants of relapse after a short (12 weeks) course of antiviral therapy and re-treatment efficacy of a prolonged course in patients with chronic hepatitis C virus genotype 2 or 3 infection. Hepatology. 2009 Feb;49(2):358-63. doi: 10.1002/hep.22679.
PubMed 19072829Farooqi JI, Farooqi RJ. Conventional interferon alfa-2b and ribavirin for 12 versus 24 weeks in HCV genotype 2 or 3. J Coll Physicians Surg Pak. 2008 Oct;18(10):620-4. doi: 10.2008/JCPSP.620624.
PubMed 18940119von Wagner M, Huber M, Berg T, Hinrichsen H, Rasenack J, Heintges T, Bergk A, Bernsmeier C, Haussinger D, Herrmann E, Zeuzem S. Peginterferon-alpha-2a (40KD) and ribavirin for 16 or 24 weeks in patients with genotype 2 or 3 chronic hepatitis C. Gastroenterology. 2005 Aug;129(2):522-7. doi: 10.1016/j.gastro.2005.05.008.
PubMed 16083709Veldt BJ, Heathcote EJ, Wedemeyer H, Reichen J, Hofmann WP, Zeuzem S, Manns MP, Hansen BE, Schalm SW, Janssen HL. Sustained virologic response and clinical outcomes in patients with chronic hepatitis C and advanced fibrosis. Ann Intern Med. 2007 Nov 20;147(10):677-84. doi: 10.7326/0003-4819-147-10-200711200-00003.
PubMed 18025443Mehta SH, Brancati FL, Strathdee SA, Pankow JS, Netski D, Coresh J, Szklo M, Thomas DL. Hepatitis C virus infection and incident type 2 diabetes. Hepatology. 2003 Jul;38(1):50-6. doi: 10.1053/jhep.2003.50291.
PubMed 12829986
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXtended Therapy in Genotype 3 Infected Patients Who do Not AChieve a Treatment Response at Week 4 (RVR) But do Achieve a Complete Early Virologic Response (cEVR)
- ClinicalTrials.gov ID
- NCT01095445
- Acronym / sponsor ID
- EXACT-R(3) / EXACT-R(3)
- Conditions
- Chronic Hepatitis C
- Keywords
- hepatitis C, genotype 3, end of treatment response, relapse rate, rapid virologic response, complete early virologic response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unlikely to recruit the adequate number of patients within a reasonable timeline
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Schering-Plough
- Study start
- Feb 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 30 Mar 2010 (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.
The purpose of this study is to evaluate the effect of 48 vs 24 weeks of treatment with Peginterferon alfa-2b plus weight-based ribavirin on Sustained Virologic Response (SVR) and relapse rates in patients infected with genotype 3 chronic hepatitis C (CHC) who do not achieve a Rapid Virologic Response (RVR) but attain a complete Early Virologic Response (cEVR).
Detailed description
This study plans to address the issue of whether increasing the duration of therapy from 24 weeks to 48 weeks with PegIFNα2b 1.5mg/kg/week and using weight-based ribavirin (15mg/kg) may reduce relapse rates and thereby increase SVR rates in patients infected with genotype 3 who fail to achieve an RVR but do achieve a complete cEVR defined as undetectable HCV RNA (ie. <50 or <15 IU/ml by 12 weeks). This study is necessary because although most patients with genotype 3 ultimately become HCV RNA undetectable during treatment, relapse after discontinuation of therapy remains a major cause of failure to achieve SVR. This is a very important issue given that to date none of the new small molecule drugs appear effective against genotype 3 meaning that at the present time patients with genotype 3 infection have no other options. Relapse is particularly common in patients with advanced liver disease but it has been shown that if SVR can be achieved in patients with advanced disease, the risk of liver failure is significantly reduced, as may be the risk of hepatocellular carcinoma (HCC). As a consequence the need for liver transplantation is diminished and survival is improved. Identifying strategies to reduce relapse and improve rates of SVR are therefore critical.
Certain individuals are at greater risk of infection with genotype 3. In the Western world, the main risk groups are current or former drug users (IDU) and immigrants raised in South Asia (India and Pakistan) where infection likely occurs early in childhood due to exposure to contaminated instruments, needles, etc.
A second potential benefit of achieving SVR is reduction in the rate of diabetes. Diabetes has been demonstrated to be more common in those infected with Hepatitis C than in the general population - this observation was made by examination of the NHANES population based database. The prelude to the development of Type 2 diabetes is insulin resistance. Insulin resistance (IR) is present in about one third of patients chronically infected with HCV - the rate being highest in those with cirrhosis and in those who are overweight or obese. Early data indicates that although the presence of insulin resistance impairs interferon responsiveness if SVR can be achieved, insulin resistance is lost. Studies of IR in individuals infected with genotype 3 HCV are lacking. Independent of HCV infection, being born South Asian is a risk factor for Type 2 diabetes.
The issue of insulin resistance and the effectiveness of antiviral therapy in chronic hepatitis C has been addressed exclusively in Caucasians infected with genotype 1. Recent data from Japan indicates that in patients with diabetes and hepatitis C successful eradication of HCV RNA may simultaneously prevent subsequent diabetes and presumably the systemic complications of this disease.
There is little data on the rate of RVR in the South Asian population as few therapeutic trials in patients with genotype 3 infections have been reported from Pakistan and India. Estimates can only be obtained from studies performed in Caucasians from Northern Europe and North America. In the trial by Shiffman the rate of RVR in those with genotype 3 infection was 62% and preliminary report from the trial of Albuferon in those with genotype 2 and 3 indicate RVR rates ranged from 44-60% in Asians -this figure included all Asians.
There are several reasons to specifically address ways to improve the outcome of antiviral therapy in patients infected with genotype 3 CHC. Firstly virtually all treatment studies report on a combined rate of SVR achieved in genotypes 2 and 3 even though the evidence has suggested that the response to therapy is different between these two genotypes. Within populations of patients with genotype 3 infection, there may be differences as well. South Asians are predominantly infected with genotype 3a, while injection drug users typically have genotype 3b infection. There are no formal trials published in the English literature of antiviral therapy in South Asians or comparing subtypes of genotype 3.
In patients infected with genotype 1 slow response to antiviral therapy i.e. lack of RVR, is associated with a significantly higher rate of relapse in those who go on to achieve undetectable HCV RNA at 12 weeks rather than at 4 weeks into treatment. Extending treatment for a further six months reduces this relapse rate considerably. By extending treatment in patients infected with genotype 3 who had previously relapsed following only 14 weeks of therapy to 24 weeks reduced relapse rates. Thus, it is anticipated that by extending treatment from 24 to 48 weeks in those who fail to achieve a RVR (i.e. slow responders) but who do achieve a complete EVR we hope to prevent relapse off treatment. A potential added benefit of achieving SVR in this patient population, many of whom are already at high risk of T2DM, is that it may reduce the virally mediated component of IR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care treatment | No intervention | –Participants will be randomized to receive only the standard 24 weeks of therapy (Peginterferon alfa-2b plus ribavirin). |
| Extended therapy | Active comparator | Drug: Peginterferon alfa-2b (Pegetron) plus ribavirin (Rebetol)Participants will be randomized to receive 24 weeks of therapy (Peginterferon alfa-2b plus ribavirin) in addition to their standard of care therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Infected with only genotype 3, hepatitis C
- Treatment naïve before current course of therapy
- A positive HCV RNA test result at Week 4 (no RVR)
- A negative HCV RNA test result at Week 12 (cEVR)
- A recent liver biopsy (within 3 years prior to study entry) is required. If the patient has either liver biopsy proven cirrhosis in the past or has splenomegaly with features of cirrhosis on ultrasound and/or thrombocytopenia (<150x109/ml) at any time in the past or has a Fibroscan reading of 10 or above or has a Fibrotest score of 0.75 or above (equivalent to F3 on the METAVIR scale), a biopsy will not be required. A copy of the latest report must be available.
Key exclusion criteria (12 listed)
- Under age 18
- Co-infection with HIV or Hepatitis B or any other HCV genotype in addition to genotype 3
- Prior treatment for Hepatitis C aside from herbal remedies
- Evidence of decompensated liver disease, such as ascites, bleeding varices, hepatic encephalopathy or jaundice (conjugated hyperbilirubinemia)
- INR > 1.3 at baseline
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-2b (Pegetron) plus ribavirin (Rebetol)Also: Pegetron, RebetolDosage Form: Pegetron - powder for solution; Rebetol - capsules Strength: Pegetron Redipen - 120 mcg per pen; Rebetol - 200 mg Route of Administration: Pegetron - subcutaneous; Rebetol - oral | Drug | Extended therapy |
Primary outcome
End of treatment response
Time frame: 24 weeks following end of therapy
Undetectable hepatitis C virus (HCV) RNA at 24 weeks following end of therapy
1 secondary outcome
Relapse rate
Time frame: 24 weeks following end of therapy
Results and safety
The study was stopped early (reason given: Unlikely to recruit the adequate number of patients within a reasonable timeline). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2011.
- Background: PubMed 14996676Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer H Jr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM; PEGASYS International Study Group. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med. 2004 Mar 2;140(5):346-55. doi: 10.7326/0003-4819-140-5-200403020-00010.
- Background: PubMed 15158341Zeuzem S, Hultcrantz R, Bourliere M, Goeser T, Marcellin P, Sanchez-Tapias J, Sarrazin C, Harvey J, Brass C, Albrecht J. Peginterferon alfa-2b plus ribavirin for treatment of chronic hepatitis C in previously untreated patients infected with HCV genotypes 2 or 3. J Hepatol. 2004 Jun;40(6):993-9. doi: 10.1016/j.jhep.2004.02.007.
- Background: PubMed 18088245Powis J, Peltekian KM, Lee SS, Sherman M, Bain VG, Cooper C, Krajden M, Deschenes M, Balshaw RF, Heathcote EJ, Yoshida EM; Canadian Pegasys Study Group. Exploring differences in response to treatment with peginterferon alpha 2a (40kD) and ribavirin in chronic hepatitis C between genotypes 2 and 3. J Viral Hepat. 2008 Jan;15(1):52-7. doi: 10.1111/j.1365-2893.2007.00889.x.
- Background: PubMed 15558712Dalgard O, Bjoro K, Hellum KB, Myrvang B, Ritland S, Skaug K, Raknerud N, Bell H. Treatment with pegylated interferon and ribavarin in HCV infection with genotype 2 or 3 for 14 weeks: a pilot study. Hepatology. 2004 Dec;40(6):1260-5. doi: 10.1002/hep.20467.
- Background: PubMed 18454508Lagging M, Langeland N, Pedersen C, Farkkila M, Buhl MR, Morch K, Dhillon AP, Alsio A, Hellstrand K, Westin J, Norkrans G; NORDynamIC Study Group. Randomized comparison of 12 or 24 weeks of peginterferon alpha-2a and ribavirin in chronic hepatitis C virus genotype 2/3 infection. Hepatology. 2008 Jun;47(6):1837-45. doi: 10.1002/hep.22253.
- Background: PubMed 15972867Mangia A, Santoro R, Minerva N, Ricci GL, Carretta V, Persico M, Vinelli F, Scotto G, Bacca D, Annese M, Romano M, Zechini F, Sogari F, Spirito F, Andriulli A. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2005 Jun 23;352(25):2609-17. doi: 10.1056/NEJMoa042608.
- Background: PubMed 17975791Dalgard O, Bjoro K, Ring-Larsen H, Bjornsson E, Holberg-Petersen M, Skovlund E, Reichard O, Myrvang B, Sundelof B, Ritland S, Hellum K, Fryden A, Florholmen J, Verbaan H; North-C Group. Pegylated interferon alfa and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3 and rapid virological response. Hepatology. 2008 Jan;47(1):35-42. doi: 10.1002/hep.21975.
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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.
E. Jenny Heathcote, MB,BS,MD,FRCP,FRCP(C) principal investigator
University Health Network - Toronto Western Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peginterferon alfa-2b (Pegetron) plus ribavirin (Rebetol) in people with Chronic Hepatitis C, run by University Health Network, Toronto at 12 sites in Canada.
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 5 inclusion and 12 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 29 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. 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?
The study was stopped early (reason given: Unlikely to recruit the adequate number of patients within a reasonable timeline). Results are not available in the source record.
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?
End of treatment response (time frame: 24 weeks following end of therapy). 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 NCT01095445, which also lists 24 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 29 Sep 2011.