A Phase 3 interventional study of Alisporivir and Peginterferon alfa-2a in Hepatitis C, sponsored by Debiopharm International SA. Terminated at 60 sites in 8 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-08-01.
Sponsored by Debiopharm International SA · Phase 3, Interventional, and Treatment
This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chronic hepatitis C (HCV) genotype 1 who failed prior treatment with a protease inhibitor (PI).
2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 6 is below the median of 100 across 1,887 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Debiopharm International SA is the lead sponsor of 50 studies on the registry; 6 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
ALV 400 mg twice daily (BID), plus PEG and RBV for 48 weeks
Drug: Alisporivir · Drug: Peginterferon alfa-2a · Drug: Ribavirin
ALV 200 mg soft gel capsules administered orally
Also known as: DEB025
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Also known as: Pegasys®
RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Also known as: Copegus®, RBV
Percentage of Participants Who Achieved Sustained Viral Response (SVR) 12 Weeks After End of Treatment (SVR12)
SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.
Time frame: 12 weeks posttreatment
Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24)
SVR24 was defined as HCV RNA laboratory value \< LOQ 24 weeks after the end of treatment.
Time frame: 24 weeks posttreatment
Percentage of Participants With HCV RNA Laboratory Value Below Level of Detection 12 Weeks After the End of Treatment (SVR12-LOD)
Level of detection (LOD) was defined as 10 IU/mL
Time frame: 12 weeks posttreatment
Percentage of Participants Who Discontinued Study Drug or Required Dose Reduction or Dose Interruption Due to Treatment-emergent Adverse Events
Time frame: 48 weeks
| Milestone | Alisporivir |
|---|---|
| Started | 6 |
| Completed | 0 |
| Not completed | 6 |
SVR12 was defined as hepatitis C (HCV) ribonucleic acid (RNA) laboratory value below level of quantification (LOQ) (i.e., 25 IU/ml) 12 weeks after the end of treatment.
No measurements were reported for this outcome.
SVR24 was defined as HCV RNA laboratory value \< LOQ 24 weeks after the end of treatment.
No measurements were reported for this outcome.
Level of detection (LOD) was defined as 10 IU/mL
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over Baseline to end of treatment (maximum exposure: 25 days) plus 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alisporivir | — | 0/6 (0%) | 5/6 (83.3%) |
| Event | Alisporivir |
|---|---|
| HeadacheNervous system disorders | 4/6 |
| PyrexiaGeneral disorders | 3/6 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/6 |
| NauseaGastrointestinal disorders | 2/6 |
| Rash PruriticSkin and subcutaneous tissue disorders | 2/6 |
| NasopharyngitisInfections and infestations | 1/6 |
| NeutropeniaBlood and lymphatic system disorders | 1/6 |
| FatigueGeneral disorders | 1/6 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/6 |
| HyperhidrosisSkin and subcutaneous tissue disorders | 1/6 |
All enrolled patients
| Age, Categorical(Participants) | Alisporivir |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 6 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Alisporivir |
|---|---|
| Female | 3 |
| Male | 3 |
This study is terminated, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Debiopharm International SA