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HepatitisPhase 3NCT01889433

An Open-label Comparative Efficacy and Safety Study of Algeron (Cepeginterferon Alfa-2b) in Treatment-naive Patients With Chronic Hepatitis C

A Phase 3 study testing Algeron and Pegasys in people with Hepatitis and Hepatitis C, run by Biocad at 19 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic hepatitis C. 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 and Pegasys
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
19 sitesin 4 countries
Study dates
10 Jul 2013to 2 Dec 2015
Phase
Phase 3
Are there results?
None posted in the registry

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.
  • Chronic HCV infection (genotypes 1а, 1b, 2, 3, 4) with detectable HCV RNA >6 month before the screening visit or abnormal ALT levels for >6 month before the screening visit.
  • Male and female patients, 18 to 70 years of age, inclusive.
  • Body mass index of 18 - 30 kg/m2.
  • Preserved protein synthetic liver function (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 treatment and 7 months after it.
  • Patient must have documentation of fibroscan within 1 year before the screening visit or agree to have a fibroscan within the screening period.

Who cannot join

  • Intolerance to IFN alfa, ribavirin or any components of this preparations confirmed by past medical history.
  • Infection by hepatitis B, A, E virus or HIV (co-infection).
  • Any other documented significant liver disease (drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, biliary cirrohosis, etc.).
  • Past history of HCV treatment with IFN alfa or pegylated IFN alfa.
  • Administration of injectable and non-injectable interferons and/or some interferon inducers for any indication (other than HCV) for one month before enrollment into the study.
  • Cholestatic hepatitis (level of conjugated bilirubin, alkaline phosphatase, G-GTP exceeding the upper normal level by more than 5 times).
Show all 21Show fewer
  • Decompensated liver cirrhosis confirmed by laboratory findings (class B, С according to Child-Pugh) or ultrasound examination.
  • Any documented autoimmune diseases (e.g., Crohn's disease, ulcerative colitis, systemic lupus erythematosus, idiopathic thrombocytopenic purpura, scleroderma, autoimmune haemolytic anemia, severe psoriasis).
  • Hemoglobin not lower than low normal level; neutrophils < 1.5 х109/L; platelets < 90 х109/L; creatinin level exceeding the upper normal level by more than 1.5 times, ALT level exceeding the upper normal level by more than 10 times.
  • Documented hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
  • Severe depression, schizophrenia, other mental disorders, which from the investigator's point of view are a contraindication for anti-viral treatment.
  • Epilepsy and/or disorder of function of the central nervous system.
  • Abnormal thyroid function (TTH level beyond the normal values).
  • Diagnosed or suspected hepatocellular carcinoma as evidenced by screening alfa-fetoprotein (AFP) of ≥ upper normal level.
  • Antinuclear antibody (ANA) titer ≥1:640 at screening and/or evidence of autoimmune hepatitis on liver biopsy.
  • Malignant neoplasms.
  • Pregnancy, lactation period.
  • Severe comorbidities (for example, severe hypertension, severe coronary heart disease, decompensated diabetes mellitus) that represent a contraindication for anti-viral treatment.
  • Documented rare hereditary diseases, such as intolerance of lactose, sucrose, fructose, lactase deficiency or glucose-galactose malabsorption.
  • Known drug or alcohol abuse or signs of drug/alcohol abuse in present, which from the investigator's point of view are a contraindication for anti-viral treatment or restrict adherence to the treatment regimen.
  • Simultaneous participation in other clinical studies less than 30 days before enrollment into this study or previous participation in this clinical study.

Trial locations and contacts

19 sites in 4 countries.

19 sites in 4 countries

Russia11 sites

  • State Budgetary Higher Vocational Education Institution A.I. Evdokimov Moscow State University of Medicine and Dentistry

    Moscow, 127473

  • State Budgetary Higher Vocational Education Institution I.M. Sechenov First Moscow State Medical University

    Moscow

  • State Public Healthcare Institution of the City of Moscow "Infectious Disease Clinical Hospital No. 1"

    Moscow

  • Federal State Budgetary Institution Research Institute of Influenza

    Saint Petersburg

  • Federal State Military Higher Vocational Education Institution S.M. Kirov Military Medical Academy

    Saint Petersburg

  • LLC Medical Company "Hepatolog"

    Samara

  • Municipal Healthcare Institution City Clinical Hospital No.2 named after V.I. Razumovsky

    Saratov

  • Smolensk Regional Clinical Hospital

    Smolensk

  • State Budgetary Higher Vocational Education Institution Smolensk State Medical Academy

    Smolensk

  • State Budgetary Higher Vocational Education Institution Stavropol State Medical Academy

    Stavropol

  • State Medical and Preventive Institution of the Tyumen Region "Advisory and Diagnostic Center"

    Tyumen

Other trials in Russia

India4 sites

  • Suyash Hospital Pvt. Ltd. Opposite M.G.M Medical College A.B. Road

    Indore, 452001

  • M V Hospital & Research Center

    Lucknow, 226003

  • Bhatia Hospital, Medical Research Society Tardeo Road, Grant Road (W)

    Mumbai, 400007

  • Medipoint Hospitals Pvt. Ltd.

    Pune, 411007

Other trials in India

Belarus2 sites

  • Gomel Regional Clinical Hospital

    Homyel, 246029

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037

Other trials in Belarus

Thailand2 sites

  • Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Siriraj Hospital

    Bangkok, 10700

  • Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

Other trials in Thailand

About this study

Official title: An Open-label Randomized Multicenter Phase III Clinical Study Comparing Safety and Efficacy of Algeron (Cepeginterferon Alfa-2b) and Ribavirin With Pegasys (Peginterferon Alfa-2a) and Ribavirin for Treatment of Patients With Chronic Hepatitis C

The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to Pegasys in combination with ribavirin in the treatment of chronic hepatitis C.

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 PCR 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 / Pegasys and ribavirin for another 12 or 36 weeks (depending on the HCV genotype). Sustained virologic response will be assessed 24 weeks after last dose of study treatment.

Being tested
Algeron, Pegasys
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

  • PegasysDrug

    Also called Peginterferon alfa-2a

    180 µg subcutaneously, once a week

Study groups in NCT01889433
Study groupRoleWhat they receive
AlgeronExperimentalAlgeron 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
PegasysActive comparatorPegasys in a dose of 180 µg subcutaneously, once a week, in combination with Rebetol, orally, at a daily dose of 800 mg for patients with genotype 2 or 3, and for genotypes 1 or 4 at a daily dose of 1000 mg (for body weight <75 kg) or 1200 mg (for body weight ≥75 kg)
Receives: Drug: Pegasys

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EVR

    Proportion 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 (5)

  1. RVR

    Proportion 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

  2. SVR (24)

    Proportion 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

  3. EOT

    Proportion of randomized patients achieving end-of-treatment response (EOT) -undetectable HCV RNA (< 15 IU/ml) at the end of treatment (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).

    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

  4. Biochemical Response

    Proportion of patients who have ALT level ≤ than upper normal level after 12 weeks of treatment, at the end of treatment (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) and 24 weeks after last dose of study treatment.

    Measured: 12, 24, 48 weeks of treatment, and 24 weeks after last dose of study treatment

  5. Histological Response

    Proportion of patients who have histological response, defined by a 1 level decrease in total METAVIR score measured on Fibroscan

    Measured: 12 weeks of treatment and 24 weeks after last dose of study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2013 (estimated)
  2. Study start10 Jul 2013
  3. Primary completion2 Dec 2015
  4. Study completion2 Dec 2015

Resources

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
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01889433
Sponsor's protocol ID
BCD-016-3
Status last verified
Jul 2018
First submitted
26 Jun 2013
Last updated
16 Jul 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Algeron and Pegasys in people with Hepatitis and Hepatitis C, run by Biocad at 19 sites in 4 countries.

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 21 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 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Russia, India, Belarus, Thailand. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

EVR (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01889433.

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 16 Jul 2018.

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