HepatitisPhase 2/3NCT01740089
Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C
A Phase 2/3 study testing Algeron, PegIntron and Ribavirin in people with Hepatitis and Hepatitis C, run by Biocad at 1 site in Russia.
Trial summary
The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis, Hepatitis C
- What is being tested?
- Algeron, PegIntron and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- Nov 2011to Dec 2013
- Phase
- Phase 2/3
- 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 to participate in the study.
- Hepatitis С virus infection (genotypes 1а, 1b, 2, 3, 4) confirmed by a positive quantitative PCR (HCV RNA > 50 IU/ml).
- Males and females aged from 18 to 70 years inclusive.
- Body mass index of 18 - 30 kg/m inclusive.
- Increased ALT level (> 40, < 400 IU/L), documented at least twice within the last 6 months.
- Preserved protein synthetic liver function (i.e. INR < 1.7, albumin > 35 g/l).
- No signs of hepatic encephalopathy or abdominal fluid retention according to clinical and ultrasound examination.
- Fertile patients and their partners agree to use barrier contraception throughout the study and 7 months after its completion.
Who cannot join
- Intolerance of IFN alpha formulations, ribavirin or any components of these drugs according to the past medical history.
- Infection by hepatitis B virus or HIV.
- Past history of HCV treatment with IFN alfa or pegylated IFN alfa formulations.
- Administration of interferons and/or interferon inducing drugs for any indication within 1 month prior to the enrollment into the study.
- Cholestatic hepatitis (conjugated bilirubin, alkaline phosphatase, ALT levels of more than 5 ULN).
- Decompensated liver cirrhosis confirmed by laboratory findings (Child-Pugh class B, С) or ultrasound examination.
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- Any documented autoimmune diseases.
- Hematologic (hemoglobin < 130 g/L for males and < 120 g/L for females; neutrophils < 1.5 х109/L; platelets < 90 х109/L) or biochemical abnormalities (creatinine level of more than 1.5 ULN, creatinine clearance less than 50 mL/min).
- Documented diagnosis of hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
- Heavy depression, any other mental disorders, which in the Investigator's opinion can be contraindications for antiviral treatment.
- Epilepsy and/or other functional disorders of the central nervous system.
- Abnormal thyroid function (TTH level beyond the normal values).
- Malignant neoplasms.
- Pregnancy, lactation period.
- Severe comorbidities (for example, severe hypertension, severe coronary heart disease, decompensated diabetes mellitus), which in the Investigator's opinion can be contraindications for antiviral treatment.
- Documented rare hereditary diseases, such as intolerance of lactose, sucrose, fructose, lactase deficiency or glucose-galactose malabsorption.
- Current alcohol or drug abuse, which in the Investigator's opinion can be contraindications for antiviral treatment or restrict treatment compliance.
- Simultaneous participation in other clinical trials or prior participation in this or another clinical trial within less than 30 days after its completion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Open-label Randomized Prospective Clinical Study of Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b) in Comparison With PegIntron (Peginterferon Alfa-2b) in the Combined Treatment of Chronic Hepatitis C
The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.
Read the detailed description
After 12 weeks of treatment, an assessment of treatment efficacy was performed, i.e. rates of rapid (after 4 weeks) and early (after 12 weeks) virologic responses according to serum HCV RNA level PCR data. In patients without virologic response after 12 weeks, AVT was discontinued, and they were withdrawn from the study. Patients with EVR were enrolled in a follow-up period. During the follow-up period, patients of the first and the second group will receive Algeron in the selected therapeutic dose in combination with ribavirin, patients of the third group - PegIntron in combination with ribavirin during 12 or 36 weeks (depending on a genotype of the virus), afterwards they will be followed up without therapy for 24 weeks.
- Conditions
- Hepatitis, Hepatitis C
- Being tested
- Algeron, PegIntron, Ribavirin
- 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 or 2.0 μg/kg of body weight weekly subcutaneously
PegIntronDrug
Also called Peginterferon alfa-2b
1.5 μg/kg/week subcutaneously in combination with ribavirin
RibavirinDrug
800-1400 mg/day orally
| Study group | Role | What they receive |
|---|---|---|
| Algeron 1.5 μg/kg | Experimental | Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg). Receives: Drug: Algeron; Drug: Ribavirin |
| Algeron 2.0 μg/kg | Experimental | Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg). Receives: Drug: Algeron; Drug: Ribavirin |
| PegIntron | Active comparator | PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg). Receives: Drug: PegIntron; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Randomized Patients Achieving Early Virologic Response (EVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) or ≥ 2log10 Decrease of Viral Load After 12 Weeks of Study Treatment.
Measured: 12 weeks
Secondary outcomes (3)
Number of Randomized Patients Achieving Rapid Virologic Response (RVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) After 4 Weeks of Treatment.
Measured: 4 weeks
Number of Randomized Patients Achieving Sustained Virologic Response (SVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) 24 Weeks After Last Dose of Study Treatment.
Measured: 24 weeks after last dose of study treatment
Number of Patients Who Have Undetectable HCV RNA (< 15 IU/ml) at the End of Treatment.
Measured: After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionDec 2013
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.
- More trials run by BiocadThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olga Znoyko, professor, Principal investigator, Moscow State University of Medicine and DentistryMarina Maevskaya, professor, Principal investigator, The First Moscow State Sechenov Medical UniversitySvetlana Kizhlo, Principal investigator, Health Department "Center for Prevention and Control of AIDS and Infectious Diseases"Natalia Petrochenkova, Principal investigator, Smolensk State Medical AcademySemen Maximov, Principal investigator, Moscow State University of Medicine and DentistryFiraja Nagimova, Principal investigator, Kazan State Medical UniversityVladimur Yakovlev, Principal investigator, 7. St. Petersburg State Institution of Health "Clinical Infectious Diseases Hospital named SP Botkin"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01740089
- Sponsor's protocol ID
- PEG-IFNа-2
- Status last verified
- Jul 2015
- First submitted
- 30 Nov 2012
- Last updated
- 18 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Open-label Randomized Prospective Clinical Study of Efficacy and Safety of Algeron (Cepeginterferon Alfa-2b) in Comparison With PegIntron (Peginterferon Alfa-2b) in the Combined Treatment of Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT01740089
- Acronym / sponsor ID
- PEG-IFNа-2
- Conditions
- Hepatitis, Hepatitis C
- Keywords
- Hepatitis C, Cepeginterferon alfa, Peginterferon, Treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Dec 2012 (estimated)
- Results
- Posted 18 Aug 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 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to determine therapeutic dose of Algeron.
Detailed description
After 12 weeks of treatment, an assessment of treatment efficacy was performed, i.e. rates of rapid (after 4 weeks) and early (after 12 weeks) virologic responses according to serum HCV RNA level PCR data. In patients without virologic response after 12 weeks, AVT was discontinued, and they were withdrawn from the study. Patients with EVR were enrolled in a follow-up period. During the follow-up period, patients of the first and the second group will receive Algeron in the selected therapeutic dose in combination with ribavirin, patients of the third group - PegIntron in combination with ribavirin during 12 or 36 weeks (depending on a genotype of the virus), afterwards they will be followed up without therapy for 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Algeron 1.5 μg/kg | Experimental | Drug: Algeron, Drug: RibavirinAlgeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg). |
| Algeron 2.0 μg/kg | Experimental | Drug: Algeron, Drug: RibavirinAlgeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg). |
| PegIntron | Active comparator | Drug: PegIntron, Drug: RibavirinPegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with 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 (8 listed)
- Signed informed consent to participate in the study.
- Hepatitis С virus infection (genotypes 1а, 1b, 2, 3, 4) confirmed by a positive quantitative PCR (HCV RNA > 50 IU/ml).
- Males and females aged from 18 to 70 years inclusive.
- Body mass index of 18 - 30 kg/m inclusive.
- Increased ALT level (> 40, < 400 IU/L), documented at least twice within the last 6 months.
Key exclusion criteria (18 listed)
- Intolerance of IFN alpha formulations, ribavirin or any components of these drugs according to the past medical history.
- Infection by hepatitis B virus or HIV.
- Past history of HCV treatment with IFN alfa or pegylated IFN alfa formulations.
- Administration of interferons and/or interferon inducing drugs for any indication within 1 month prior to the enrollment into the study.
- Cholestatic hepatitis (conjugated bilirubin, alkaline phosphatase, ALT levels of more than 5 ULN).
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 or 2.0 μg/kg of body weight weekly subcutaneously | Drug | Algeron 1.5 μg/kg, Algeron 2.0 μg/kg |
| PegIntronAlso: Peginterferon alfa-2b1.5 μg/kg/week subcutaneously in combination with ribavirin | Drug | PegIntron |
| Ribavirin800-1400 mg/day orally | Drug | Algeron 1.5 μg/kg, Algeron 2.0 μg/kg, PegIntron |
Primary outcome
Number of Randomized Patients Achieving Early Virologic Response (EVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) or ≥ 2log10 Decrease of Viral Load After 12 Weeks of Study Treatment.
Time frame: 12 weeks
3 secondary outcomes
Number of Randomized Patients Achieving Rapid Virologic Response (RVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) After 4 Weeks of Treatment.
Time frame: 4 weeks
Number of Randomized Patients Achieving Sustained Virologic Response (SVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) 24 Weeks After Last Dose of Study Treatment.
Time frame: 24 weeks after last dose of study treatment
Number of Patients Who Have Undetectable HCV RNA (< 15 IU/ml) at the End of Treatment.
Time frame: After 24 weeks of treatment for patients with genotype 2 or 3 and after 48 weeks of treatment for patients with genotype 1 or 4.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
- 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.
Olga Znoyko, professor principal investigator
Moscow State University of Medicine and Dentistry
Marina Maevskaya, professor principal investigator
The First Moscow State Sechenov Medical University
Svetlana Kizhlo principal investigator
Health Department "Center for Prevention and Control of AIDS and Infectious Diseases"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Algeron, PegIntron and Ribavirin in people with Hepatitis and Hepatitis C, run by Biocad at 1 site 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 8 inclusion and 18 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 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 18 Aug 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?
Number of Randomized Patients Achieving Early Virologic Response (EVR) - Negative PCR Result for HCV RNA (< 15 IU/ml) or ≥ 2log10 Decrease of Viral Load After 12 Weeks of Study Treatment. (time frame: 12 weeks). 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 18 Aug 2015.