A Study of Debio 025 (Alisporivir) Combined With Peg-IFNα2a and Ribavirin in Treatment naïve Chronic Hepatitis C Genotype 1 Patients
NCT ID: NCT00854802
Last Updated: 2016-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
290 participants
INTERVENTIONAL
2009-01-31
2010-09-30
Brief Summary
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Detailed Description
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Patients are randomised into 1 of 4 arms receiving either Debio 025/peg-IFNα2a/ribavirin triple therapy for a fixed treatment duration of 48 weeks (Treatment A) or 24 weeks (Treatment B), Debio 025/peg-IFNα2a/ribavirin triple therapy for a response-based treatment duration of 24 or 48 weeks (Treatment C), or blinded SOC treatment for 48 weeks (Treatment D). Follow-up is 24 weeks in all treatment arms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Debio 025 600 mg + peg-IFNα2a + ribavirin - 48 weeks
Participants receive Debio 025 600 mg orally twice daily for 7 days (loading dose) followed by Debio 025 600 mg orally once daily for 47 weeks + peg-IFNα2a 180 µg subcutaneously (sc) once weekly for 48 weeks + ribavirin 1000 or 1200 mg (weight based) orally daily for 48 weeks.
Debio 025
Debio 025 supplied in soft gel capsules
Peg-IFNα2a
Peg-IFNα2a supplied in pre-filled syringes
Ribavirin
Ribavirin supplied in tablets
Debio 025 600 mg + peg-IFNα2a + ribavirin - 24 weeks
Participants receive Debio 025 600 mg orally twice daily for 7 days (loading dose) followed by Debio 025 600 mg orally once daily for 23 weeks + peg-IFNα2a 180 µg sc once weekly for 24 weeks + ribavirin 1000 or 1200 mg (weight based) orally daily for 24 weeks.
Debio 025
Debio 025 supplied in soft gel capsules
Peg-IFNα2a
Peg-IFNα2a supplied in pre-filled syringes
Ribavirin
Ribavirin supplied in tablets
Debio 025 600 mg + peg-IFNα2a + ribavirin - 24 or 48 weeks
Participants receive Debio 025 600 mg orally twice daily for 7 days (loading dose) followed by Debio 025 600 mg orally once daily for 23 or 47 weeks + peg-IFNα2a 180 µg sc once weekly for 24 or 48 weeks + ribavirin 1000 or 1200 mg (weight based) orally daily for 24 or 48 weeks. Participants who achieve a rapid viral response, defined as having undetectable hepatitis C virus RNA at week 4, are treated for 24 weeks; other patients are treated for 48 weeks.
Debio 025
Debio 025 supplied in soft gel capsules
Peg-IFNα2a
Peg-IFNα2a supplied in pre-filled syringes
Ribavirin
Ribavirin supplied in tablets
Debio 025 placebo + peg-IFNα2a + ribavirin - 48 weeks
Participants receive Debio 025 placebo orally twice daily for 7 days followed by Debio 025 placebo orally once daily for 47 weeks + peg-IFNα2a 180 µg subcutaneously (sc) once weekly for 48 weeks + ribavirin 1000 or 1200 mg (weight based) orally daily for 48 weeks.
Peg-IFNα2a
Peg-IFNα2a supplied in pre-filled syringes
Ribavirin
Ribavirin supplied in tablets
Debio 025 placebo
Debio 025 placebo supplied in soft gel capsules
Interventions
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Debio 025
Debio 025 supplied in soft gel capsules
Peg-IFNα2a
Peg-IFNα2a supplied in pre-filled syringes
Ribavirin
Ribavirin supplied in tablets
Debio 025 placebo
Debio 025 placebo supplied in soft gel capsules
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≥ 18 and ≤ 32 kg/m\^2.
* Hepatitis B surface antigen (HbsAg) negative and HIV-1 negative.
* Serological diagnosis of chronic hepatitis C viral infection genotype 1 for \> 6 months.
* Chronic liver disease consistent with chronic hepatitis C infection on a biopsy or FibroScan® obtained within the past 24 months (36 months for patients with incomplete/transition to cirrhosis).
* Previously untreated for hepatitis C virus (HCV) infection (approved or investigational drug).
* Plasma HCV RNA level lower limit ≥ 100 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent; no upper limit.
* Neutrophil count ≥ 1500/µL; hemoglobin (Hb) ≥ 12g/dL for females and ≥ 13g/dL for males; platelets ≥ 90,000/µL.
* Patients with incomplete/transition to cirrhosis on biopsy or an elasticity score between 9.5 and 14 kPa on FibroScan must have an abdominal ultrasound (US), computed tomographic (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma (within 2 months prior to randomisation) and a serum alpha-foetoprotein (AFP) \< 100 ng/mL.
* Aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) \< 5 times the upper limit of normal.
* Normal or compensated liver function and absence of complicated portal hypertension as documented by the following:
* No history of bleeding oesophageal varices;
* Absence of ascites;
* Absence of encephalopathy;
* Albumin ≥ 35 g/L;
* Total bilirubin ≤ 1.8 mg/dL (≤ 30 µmol/L);
* Prothrombin (INR ≤ 1.5).
* Creatinine clearance \> 50 mL/min.
* Thyroid stimulating hormone (TSH) within normal range;
* All patients should be informed about Debio 025 and ribavirin foetotoxicity:
* Females may participate if they are surgically sterile or post-menopausal. Pre-menopausal females may participate if they use 2 reliable contraceptive methods (oral contraceptive + barrier method). The contraceptive regimen must be maintained during the treatment period and for 4 months after the last Debio 025 or ribavirin dose.
* Male patients must be surgically sterile or use 2 reliable contraceptive methods (oral contraceptive + barrier method). The contraceptive regimen must be maintained during the treatment period and for 7 months after the last Debio 025 or ribavirin dose.
* Signed informed consent before any study procedures.
* Negative pregnancy test within one week of first investigational product administration for female patients of child bearing potential.
Exclusion Criteria
* HCV genotype different from genotype 1.
* Any previous HCV treatment (approved or investigational).
* Histologic evidence of complete hepatic cirrhosis (including compensated cirrhosis) based on a previous liver biopsy (if available).
* Ongoing or recent use of any other medication (including over the counter medication and herbal products) within 2 weeks before study start or within 5 drug half-lives of that medication (whichever is longer) that are known inhibitors/inducers of cytochrome P450 (CYP450) 3A, substrates of P-glycoprotein 1 (P-gP), or substrates/inhibitors of organic anion-transporting polypeptides (OATP), multidrug resistance-associated protein 2 (MRP2), or bile salt export pump (BSEP) and are mentioned in the list of unauthorised medications;
* Any medical contraindications to peg-IFNα2a and/or ribavirin treatment;
* Any other cause of relevant liver disease other than HCV including but not limited to hepatitis B virus (HBV), drug- or alcohol-related cirrhosis, autoimmune hepatitis, haemochromatosis, Wilson's disease, nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), or primary biliary cirrhosis (PBC).
* Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the patient participating in and completing the study. Patients with risk factors (hypertension or diabetes) need to have an ophthalmologic investigation (including fundoscopy).
* History of moderate, severe, or uncontrolled psychiatric disease, especially depression, including a history of hospitalisation or prior suicidal attempt.
* Uncontrolled arterial hypertension, ie, patients with systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg.
* History of pancreatitis, uncontrolled diabetes mellitus, or retinopathy.
* Anti-nuclear antibody (ANA) titre \> 1:640 at screening and/or evidence of autoimmune hepatitis on liver biopsy.
* Alcohol consumption \> 20 g/day for females and \> 30 g/day for males.
* History of major organ transplantation with an existing functional graft.
* Pregnancy or lactation.
* Haemoglobinopathies (thalassaemia major, sickle cell anaemia or drepanocytosis).
* Familial history of severe neonatal cholestasis or pregnancy cholestasis.
* Evidence of an active or suspected cancer, or a history of malignancy where the risk of recurrence is ≥ 20% within 2 years.
18 Years
65 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Debiopharm International SA
INDUSTRY
Responsible Party
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Principal Investigators
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Rafael Crabbé, MD
Role: STUDY_DIRECTOR
Debiopharm International SA
Locations
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Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
C.H.U - Hôpital Henri-Mondor
Créteil, , France
C.H.U de Lyon Hôpital de l'Hôtel Dieu
Lyon, , France
Hôpital de l'Archet 2
Nice, , France
C.H.U Hôpital Cochin
Paris, , France
C.H.U - Hôpital Saint Antoine
Paris - Saint Antoine, , France
Hôpital du Haut-Levêque - C.H.U de Bordeaux
Pessac, , France
C.H.U de Nancy-Hôpital Brabois
Vandœuvre-lès-Nancy, , France
Charité - Universitatsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Center for HIV and Hepatogastroenterology
Düsseldorf, , Germany
Universitätsklinikum Essen
Essen, , Germany
J.W. Goethe University Hospital
Frankfurt am Main, , Germany
Albert-Ludwigs-Universität Freiburg, Universitätsk
Freiburg im Breisgau, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Medizinische Universitätsklinik
Heidelberg, , Germany
Johannes Gutenberg-Universitaet Mainz
Mainz, , Germany
Policlinico S.Orsola Malpighi
Bologna, , Italy
Mangiagalli e Regina Elena di Milano
Milan, , Italy
Seconda Università di Napoli- Secondo Policlinico
Napoli, , Italy
"Policlinico ""Paolo Giaccone"" dell'Università di
Palermo, , Italy
Az. Osp. Universitaria S. Giovanni Battista
Torino, , Italy
Wojewódzki Szpital Specjalistyczny im. K. Dluskieg
Bialystok, , Poland
Wojewódzki Szpital Obserwacyjno-Zakazny im. Tadeus
Bydgoszcz, , Poland
Szpital Specjalistyczny w Chorzowie
Chorzów, , Poland
Wojewódzki Szpital Zespolony w Kielcach
Kielce, , Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla I
Krakow, , Poland
Wojewódzki Szpital Specjalstyczny im. Wl. Biegansk
Lódz, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Woj
Warsaw, , Poland
Spitalul Clinic Colentina
Bucharest, , Romania
Institutul Clinic Fundeni
Bucharest, , Romania
Centrul de Diagnostic si Tratament Dr. Victor Babe
Bucharest, , Romania
"Spitalul Clinic de Urgenta ""Prof. dr. Octavian F
Cluj-Napoca, , Romania
Institutul de Gastroenterologie si Hepatologie
Iași, , Romania
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario Puerta de Hierro
Madrid, , Spain
Hospital Universitario Nuestra Señora de Valme
Seville, , Spain
Countries
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References
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Paeshuyse J, Kaul A, De Clercq E, Rosenwirth B, Dumont JM, Scalfaro P, Bartenschlager R, Neyts J. The non-immunosuppressive cyclosporin DEBIO-025 is a potent inhibitor of hepatitis C virus replication in vitro. Hepatology. 2006 Apr;43(4):761-70. doi: 10.1002/hep.21102.
Inoue K, Umehara T, Ruegg UT, Yasui F, Watanabe T, Yasuda H, Dumont JM, Scalfaro P, Yoshiba M, Kohara M. Evaluation of a cyclophilin inhibitor in hepatitis C virus-infected chimeric mice in vivo. Hepatology. 2007 Apr;45(4):921-8. doi: 10.1002/hep.21587.
Flisiak R, Horban A, Gallay P, Bobardt M, Selvarajah S, Wiercinska-Drapalo A, Siwak E, Cielniak I, Higersberger J, Kierkus J, Aeschlimann C, Grosgurin P, Nicolas-Metral V, Dumont JM, Porchet H, Crabbe R, Scalfaro P. The cyclophilin inhibitor Debio-025 shows potent anti-hepatitis C effect in patients coinfected with hepatitis C and human immunodeficiency virus. Hepatology. 2008 Mar;47(3):817-26. doi: 10.1002/hep.22131.
Reesink HW, Zeuzem S, Weegink CJ, Forestier N, van Vliet A, van de Wetering de Rooij J, McNair L, Purdy S, Kauffman R, Alam J, Jansen PL. Rapid decline of viral RNA in hepatitis C patients treated with VX-950: a phase Ib, placebo-controlled, randomized study. Gastroenterology. 2006 Oct;131(4):997-1002. doi: 10.1053/j.gastro.2006.07.013.
Pawlotsky JM. Treatment of hepatitis C: don't put all your eggs in one basket! Gastroenterology. 2007 Apr;132(4):1611-5. doi: 10.1053/j.gastro.2007.03.014. No abstract available.
Dienstag JL, McHutchison JG. American Gastroenterological Association technical review on the management of hepatitis C. Gastroenterology. 2006 Jan;130(1):231-64; quiz 214-7. doi: 10.1053/j.gastro.2005.11.010. No abstract available.
Zeuzem S, Buti M, Ferenci P, Sperl J, Horsmans Y, Cianciara J, Ibranyi E, Weiland O, Noviello S, Brass C, Albrecht J. Efficacy of 24 weeks treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia. J Hepatol. 2006 Jan;44(1):97-103. doi: 10.1016/j.jhep.2005.10.003. Epub 2005 Nov 7.
Watashi K, Hijikata M, Hosaka M, Yamaji M, Shimotohno K. Cyclosporin A suppresses replication of hepatitis C virus genome in cultured hepatocytes. Hepatology. 2003 Nov;38(5):1282-8. doi: 10.1053/jhep.2003.50449.
Watashi K, Ishii N, Hijikata M, Inoue D, Murata T, Miyanari Y, Shimotohno K. Cyclophilin B is a functional regulator of hepatitis C virus RNA polymerase. Mol Cell. 2005 Jul 1;19(1):111-22. doi: 10.1016/j.molcel.2005.05.014.
Rice CM, You S. Treating hepatitis C: can you teach old dogs new tricks? Hepatology. 2005 Dec;42(6):1455-8. doi: 10.1002/hep.20975.
Ishii N, Watashi K, Hishiki T, Goto K, Inoue D, Hijikata M, Wakita T, Kato N, Shimotohno K. Diverse effects of cyclosporine on hepatitis C virus strain replication. J Virol. 2006 May;80(9):4510-20. doi: 10.1128/JVI.80.9.4510-4520.2006.
Yang F, Robotham JM, Nelson HB, Irsigler A, Kenworthy R, Tang H. Cyclophilin A is an essential cofactor for hepatitis C virus infection and the principal mediator of cyclosporine resistance in vitro. J Virol. 2008 Jun;82(11):5269-78. doi: 10.1128/JVI.02614-07. Epub 2008 Apr 2.
Related Links
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Study sponsor
Other Identifiers
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2008-004605-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CDEB025A2205
Identifier Type: OTHER
Identifier Source: secondary_id
Debio 025-HCV-205
Identifier Type: -
Identifier Source: org_study_id
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