HepatitisPhase 3NCT02103439
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
A Phase 3 study testing Algeron and PegIntron in people with Hepatitis and Hepatitis C, run by Biocad at 6 sites in Russia.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis, Hepatitis C, Hepatitis C/ Human Immunodeficiency Virus Coinfection
- What is being tested?
- Algeron and PegIntron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 6 sitesRussia
- Study dates
- 6 Jun 2013to 26 Aug 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed Informed Consent Form.
- Chronic hepatitis C (genotypes 1а, 1b, 2, 3, 4) confirmed by positive result of hepatitis C virus ribonucleic acid during > 6 months before screening visit or accompanied with increase in alanine aminotransferase (ALT) level > 6 months before screening visit.
- Confirmed Human Immunodeficiency Virus-1 infection based on enzyme-linked immunosorbent assay and immune blotting results.
- Clinically sustained phase of Human Immunodeficiency Virus-1 infection with absence of active opportunistic Human Immunodeficiency Virus-associated diseases for at least 30 calendar days before inclusion in the study.
- Level of CD4+-lymphocytes is not less than 500 cells/mm3 for patients not requiring highly active antiretroviral therapy and which will not be assigned to antiretroviral therapy during the study period.
- For patients receiving sustained highly active antiretroviral therapy for not less than 12 weeks and planning to continue comply with this treatment regimen during the following 24 weeks, level of CD4+-lymphocytes ≥300 cells/mm3, Human Immunodeficiency Virus ribonucleic acid ≤50 copies/ml.
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- Men and women aged 18 to 70 inclusively.
- Body mass index in the range of 18 - 30 kg/m2 inclusively .
- Preserved protein-synthetizing liver function (International Normalized Ratio < 1.7, albumin > 35 g/l).
- Absence of signs of hepatic encephalopathy and ascites according to clinical examination and ultrasound examination.
- Patients with preserved child-bearing potential and their partners agree to use barrier method of contraception during the whole period of therapy and during 7 months after the treatment completion.
- Documentary confirmed results of liver elastography (fibroscan) during last year before enrollment in the study or patient agreement to undergo this examination during screening.
Who cannot join
- Intolerance of alfa-interferons, ribavirin or any components of tested drug product based on medical history.
- Presence of hepatitis B, A, E markers.
- Presence of documentary confirmed clinically significant concurrent liver diseases (alcoholic liver cirrhosis, drug-induced liver cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis, biliary cirrhosis etc.).
- Past history of Hepatitis C Virus treatment with interferon alfa or pegylated interferon alfa.
- For patients receiving sustained highly active antiretroviral therapy - presence of nevirapine, stavudine, zidovudine, didanosine in treatment regimen.
- Use of injectable and non-injectable interferons alfa/ interferon inducers for any indication (except for hepatitis C), radiotherapy, cytotoxic chemotherapy for one month prior to inclusion in the study.
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- Cholestic hepatitis (level of direct bilirubin, alkaline phosphatase, gamma glutamyltransferase, exceeding upper normal limit in > 5 times).
- Decompensated liver cirrhosis confirmed with results of laboratory analyses (Child-Pugh class B, C) or ultrasound examination.
- Any documentary confirmed autoimmune diseases (such as Crohn's disease, ulcerative colitis, systemic lupus erythematosus, idiopathic thrombocytopenic purpura, scleroderma, autoimmune hemolytic anemia, severe psoriasis).
- Deviations of hematologic (hemoglobin less than lower normal limit; neutrophils < 1.5 x 10^9/l; thrombocytes < 90 x 10^9/ l) and biochemical (creatinine level > 1.5 times higher upper normal limit, ALT is > 10 times higher upper normal limit) parameters.
- Documentary confirmed diagnosis of hemoglobinopathy (for example, thalassemia, sickle-cell anemia).
- Severe depression, schizophrenia, any other mental disorders which according to the investigator are contraindications for antiviral treatment.
- Epilepsy and/or central nervous system disorder.
- Disorder of thyroid function (level of thyroid stimulating hormone out of the normal range).
- Documentary confirmed or suspected hepatocellular carcinoma based on the results of alfa-fetoprotein (AFP) assay ≥ upper normal limit.
- Antinuclear antibodies (ANA) titer measured at screening is not less than 1:640 or documentary confirmed signs of autoimmune hepatitis based on the results of biopsy.
- Documentary confirmed malignant neoplasms.
- Documentary confirmed lung diseases associated with respiratory failure.
- Treatment of Human Immunodeficiency Virus-1 with immunotherapeutic vaccines within 90 days prior to screening.
- Necessity in assignment of antimycobacterial therapy.
- Pregnancy, lactation period.
- Documentary confirmed retinopathy (for example, cytomegalovirus retinitis, macular degeneration).
- Severe concurrent diseases (for example, severe arterial hypertension, sever coronary heart disease, heart failure, decompensated diabetes mellitus and other) which are contraindications for antiviral therapy according to the investigator opinion.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
State Public Healthcare Institution National Center for the Prevention and Control of AIDS and other infectious diseases of the Ministry of Health of the Republic of Tatarstan
Kazan', Tatarstan Republic, 420097
State Institution of Nizhny Novgorod region "Regional Center for Prevention and Control of AIDS and other infectious diseases"
Nizhny Novgorod, 603005
State Healthcare Institution Center for the Prevention and Control of AIDS and infectious diseases of the city, St.Petersburg CityHealth Department
Saint Petersburg, 190103
State Budgetary Higher Vocational Education Institution V.I. Razumovsky Saratov State University of medicine
Saratov, 410012
State Budgetary Higher Vocational Education Institution Pacific State Medical University, Ministry of Health of the Russian Federation
Vladivostok, 690002
State Healthcare Institution "Volgograd Regional Center for the Prevention and Control of AIDS and infectious diseases"
Volgograd, 400040
About this study
Official title: Multicenter Open-label Randomized, Comparative Clinical Study to Evaluate Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b, CJSC "BIOCAD", Russia) With Ribavirin Compared to PegIntron (Peginterferon Alfa-2b, Schering-Plough Labo N.V., Belgium) With Ribavirin in Treatment of Chronic Hepatitis C in Human Immunodeficiency Virus-1 Infected Patients
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
Read the detailed description
The course of treatment in both groups shall be 12 weeks, and efficacy analysis, i.e. rate of rapid (after the 4th week) and early (after the 12th week) virologic response will be based on polymerase chain reaction data. For patients with treatment failure after the 12th week the antiviral therapy shall be discontinued. All patients who require further anti-viral treatment will receive a combination treatment with Algeron / PegIntron and ribavirin for another 36 weeks. Sustained virologic response will be assessed 24 weeks after last dose of study treatment.
- Being tested
- Algeron, PegIntron
- Keywords
- Hepatitis C, Cepeginterferon alfa, Peginterferon, Treatment
- Medical subject headings
- Hepatitis, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlgeronDrug
Also called Cepeginterferon alfa-2b
1.5 µg/kg of body weight subcutaneously, once a week
PegIntronDrug
Also called peginterferon alfa-2b
1.5 µg/kg of body weight subcutaneously, once a week
| Study group | Role | What they receive |
|---|---|---|
| Algeron | Experimental | Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg) Receives: Drug: Algeron |
| PegIntron | Active comparator | PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg). Receives: Drug: PegIntron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Virological Response
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
Measured: 12 weeks
Early Virological Response in Patients With Different Hepatitis C Virus Genotypes
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
Measured: 12 weeks
Secondary outcomes (4)
Rapid Virological Response
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
Measured: 4 weeks
Rapid Virological Response in Patients With Different Hepatitis C Virus Genotypes
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
Measured: 4 weeks
Viral Breakthrough
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
Measured: screening data and at 4 or 12 weeks of treatment.
Biochemical Response
Proportion of patients in each group with alanine aminotransferase level ≤ upper normal limit after 12 weeks of therapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study start6 Jun 2013
- Primary completion26 Aug 2015
- Study completion26 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HepatitisStudies of the same condition, open and under way.
- 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
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Moshkovich, M.D., Principal investigator, State Institution of Nizhny Novgorod region "Regional Center for Prevention and Control of AIDS and other infectious diseases"Firaya Nagimova, PhD, Principal investigator, State Public Healthcare Institution National Center for the Prevention and Control of AIDS and other infectious diseases of the Ministry of Health of the Republic of TatarstanOleg Kozyrev, PhD, Principal investigator, State Healthcare Institution "Volgograd Regional Center for the Prevention and Control of AIDS and infectious diseases"Andrey Shuldyakov, M.D., PhD, Principal investigator, State Budgetary Higher Vocational Education Institution V.I. Razumovsky Saratov State University of medicineVadim Rassokhin, PhD, Principal investigator, State Healthcare Institution Center for the Prevention and Control of AIDS and infectious diseases of the city, St.Petersburg CityHealth DepartmentLidia Sklar, M.D., PhD, Principal investigator, State Budgetary Higher Vocational Education Institution Pacific State Medical University, Ministry of Health of the Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103439
- Sponsor's protocol ID
- BCD-016-4
- Status last verified
- Jul 2018
- First submitted
- 1 Apr 2014
- Last updated
- 9 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Open-label Randomized, Comparative Clinical Study to Evaluate Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b, CJSC "BIOCAD", Russia) With Ribavirin Compared to PegIntron (Peginterferon Alfa-2b, Schering-Plough Labo N.V., Belgium) With Ribavirin in Treatment of Chronic Hepatitis C in Human Immunodeficiency Virus-1 Infected Patients
- ClinicalTrials.gov ID
- NCT02103439
- Acronym / sponsor ID
- BCD-016-4
- Keywords
- Hepatitis C, Cepeginterferon alfa, Peginterferon, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2013 (actual)
- Primary completion
- 26 Aug 2015 (actual)
- Study completion
- 26 Aug 2015 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Posted 21 Jul 2015
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 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
Detailed description
The course of treatment in both groups shall be 12 weeks, and efficacy analysis, i.e. rate of rapid (after the 4th week) and early (after the 12th week) virologic response will be based on polymerase chain reaction data. For patients with treatment failure after the 12th week the antiviral therapy shall be discontinued. All patients who require further anti-viral treatment will receive a combination treatment with Algeron / PegIntron and ribavirin for another 36 weeks. Sustained virologic response will be assessed 24 weeks after last dose of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Algeron | Experimental | Drug: AlgeronAlgeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg) |
| PegIntron | Active comparator | Drug: PegIntronPegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed Informed Consent Form.
- Chronic hepatitis C (genotypes 1а, 1b, 2, 3, 4) confirmed by positive result of hepatitis C virus ribonucleic acid during > 6 months before screening visit or accompanied with increase in alanine aminotransferase (ALT) level > 6 months before screening visit.
- Confirmed Human Immunodeficiency Virus-1 infection based on enzyme-linked immunosorbent assay and immune blotting results.
- Clinically sustained phase of Human Immunodeficiency Virus-1 infection with absence of active opportunistic Human Immunodeficiency Virus-associated diseases for at least 30 calendar days before inclusion in the study.
- Level of CD4+-lymphocytes is not less than 500 cells/mm3 for patients not requiring highly active antiretroviral therapy and which will not be assigned to antiretroviral therapy during the study period.
Key exclusion criteria (23 listed)
- Intolerance of alfa-interferons, ribavirin or any components of tested drug product based on medical history.
- Presence of hepatitis B, A, E markers.
- Presence of documentary confirmed clinically significant concurrent liver diseases (alcoholic liver cirrhosis, drug-induced liver cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis, biliary cirrhosis etc.).
- Past history of Hepatitis C Virus treatment with interferon alfa or pegylated interferon alfa.
- For patients receiving sustained highly active antiretroviral therapy - presence of nevirapine, stavudine, zidovudine, didanosine in treatment regimen.
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 |
|---|---|---|
| AlgeronAlso: Cepeginterferon alfa-2b1.5 µg/kg of body weight subcutaneously, once a week | Drug | Algeron |
| PegIntronAlso: peginterferon alfa-2b1.5 µg/kg of body weight subcutaneously, once a week | Drug | PegIntron |
Primary outcome
Early Virological Response
Time frame: 12 weeks
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
Early Virological Response in Patients With Different Hepatitis C Virus Genotypes
Time frame: 12 weeks
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
4 secondary outcomes
Rapid Virological Response
Time frame: 4 weeks
Rapid Virological Response in Patients With Different Hepatitis C Virus Genotypes
Time frame: 4 weeks
Viral Breakthrough
Time frame: screening data and at 4 or 12 weeks of treatment.
Biochemical Response
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gregory Moshkovich, M.D. principal investigator
State Institution of Nizhny Novgorod region "Regional Center for Prevention and Control of AIDS and other infectious diseases"
Firaya Nagimova, PhD principal investigator
State Public Healthcare Institution National Center for the Prevention and Control of AIDS and other infectious diseases of the Ministry of Health of the Republic of Tatarstan
Oleg Kozyrev, PhD principal investigator
State Healthcare Institution "Volgograd Regional Center for the Prevention and Control of AIDS and infectious diseases"
6 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 Algeron and PegIntron in people with Hepatitis and Hepatitis C, run by Biocad at 6 sites in Russia.
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 12 inclusion and 23 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Russia. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Early Virological Response (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2018.