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An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and and PegIntron (Peginterferon Alfa-2b) in Combination With Ribavirin as Combined Treatment of Chronic Hepatitis C in Human Immunodeficiency Virus-1 Infected Patients
Phase 3 trial testing Algeron in Hepatitis in 140 participants. Completed in 26 August 2015.
| Lead sponsor | Biocad |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 140 |
| Start date | 6 June 2013 |
| Primary completion | 26 August 2015 |
| Estimated completion | 26 August 2015 |
| Sites | 6 locations across Russia |
Biocad — full company profile →
Adults 18 to 70, any sex, with Hepatitis or Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of randomized patients achieving early virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (\< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment
| Group | Value | 95% CI |
|---|---|---|
| Algeron | 90.0 | |
| PegIntron | 81.4 |
Proportion of randomized patients achieving rapid virologic response - negative polymerase chain reaction result for Hepatitis C Virus ribonucleic acid (\< 15 IU/ml) after 4 weeks of treatment
| Group | Value | 95% CI |
|---|---|---|
| Algeron | 51.4 | |
| PegIntron | 37.1 |
Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving rapid virological response - negative polymerase chain reaction result for HCV ribonucleic acid (\< 15 IU/ml) after 4 weeks of treatment
| Group | Value | 95% CI |
|---|---|---|
| Algeron - HCV-1 | 23.5 | |
| Algeron - HCV-2/3 | 77.8 | |
| PegIntron - HCV-1 | 21.2 | |
| PegIntron - HCV-2/3 | 51.4 |
Proportion of patients in each groups with level of Hepatitis C Virus ribonucleic acid \> 15 IU/ml after Hepatitis C Virus ribonucleic acid was not present or Hepatitis C Virus ribonucleic acid was increased by more than 1log10 from baseline at 4 or 12 weeks of treatment
| Group | Value | 95% CI |
|---|---|---|
| Algeron | 0 | |
| PegIntron | 0 |
Proportion of randomized patients with different Hepatitis C Virus (HCV) genotypes achieving early virologic response - negative polymerase chain reaction result for HCV ribonucleic acid (\< 15 IU/ml) or ≥ 2log10 decrease of viral load after 12 weeks of study treatment
| Group | Value | 95% CI |
|---|---|---|
| Algeron - HCV-1 | 82.4 | |
| Algeron - HCV-2/3 | 97.2 | |
| PegIntron - HCV-1 | 75.8 | |
| PegIntron - HCV-2/3 | 88.5 |
Proportion of patients in each group with alanine aminotransferase level ≤ upper normal limit after 12 weeks of therapy
| Group | Value | 95% CI |
|---|---|---|
| Algeron | 68.6 | |
| PegIntron | 82.9 |
Time frame: 12 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Algeron | PegIntron |
|---|---|---|---|
| CTCAE 4.03 Grade 4 anemia | Blood and lymphatic system disorders | — | — |
| cavitary pulmonary tuberculosis | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Algeron | PegIntron |
|---|---|---|---|
| Leucopenia | Blood and lymphatic system disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Lymphopenia | Blood and lymphatic system disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Flu-like syndrome | General disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Increased triglycerides | Metabolism and nutrition disorders | — | — |
| Direct bilirubin increased | Hepatobiliary disorders | — | — |
| Increased gamma glumamyltransferase | Hepatobiliary disorders | — | — |
| Increased aspartate aminotranferase | Hepatobiliary disorders | — | — |
| Hyperbilirubinaemia | Hepatobiliary disorders | — | — |
| Increased albumin | Hepatobiliary disorders | — | — |
| Increased alanine aminotranferase | Hepatobiliary disorders | — | — |
| Asthenia (weakness, fatigue) | General disorders | — | — |
| Increased cholesterol | Metabolism and nutrition disorders | — | — |
| Hypoglycemia | Endocrine disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Need in Rebetol dose correction due to anemia | Blood and lymphatic system disorders | — | — |
| Increased creatinine | Renal and urinary disorders | — | — |
| Decreased level of CD4+ lymphocytes | Blood and lymphatic system disorders | — | — |
| Need in filgrastim | Blood and lymphatic system disorders | — | — |
| Hyperglycemia | Endocrine disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Stomach pain | Gastrointestinal disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Increased alkaline phosphotase | Hepatobiliary disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Skin redness | Skin and subcutaneous tissue disorders | — | — |
| Irritability, emotional lability | Psychiatric disorders | — | — |
| Sleep disorders | Nervous system disorders | — | — |
| Decreased appetite | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Skin itch | Skin and subcutaneous tissue disorders | — | — |
| Skin dryness and exfoliation | Skin and subcutaneous tissue disorders | — | — |
| Increased thyroid stimulating hormone | Endocrine disorders | — | — |
| Hyperemia | Skin and subcutaneous tissue disorders | — | — |
Most-reported serious reactions: CTCAE 4.03 Grade 4 anemia, cavitary pulmonary tuberculosis.
Data from ClinicalTrials.gov NCT02103439 adverse events section.
The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic hepatitis C in Human Immunodeficiency Virus-1 infected patients
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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