NCT01889433

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2013

Geographic Reach
4 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2013

Completed
12 days until next milestone

Study Start

First participant enrolled

July 10, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2015

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

2.4 years

First QC Date

June 26, 2013

Last Update Submit

July 13, 2018

Conditions

HepatitisHepatitis C

Keywords

Hepatitis CCepeginterferon alfaPeginterferonTreatment

Outcome Measures

Primary Outcomes (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

    12 weeks

Secondary Outcomes (5)

  • RVR

    4 weeks

  • SVR (24)

    24 weeks after last dose of study treatment

  • EOT

    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

  • Biochemical Response

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

  • Histological Response

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

Other Outcomes (1)

  • Immunogenicity

    Week 0, 12, 24, and additionally for patients with HCV 1, 4 genotype - week 48 after first administration of Algeron / Pegasys and 24 weeks after last dose of study treatment

Study Arms (2)

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).

Drug: Algeron

Pegasys

ACTIVE COMPARATOR

Pegasys 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)

Drug: Pegasys

Interventions

AlgeronDRUG

1.5 µg/kg of body weight subcutaneously, once a week

Also known as: Cepeginterferon alfa-2b
Algeron
PegasysDRUG

180 µg subcutaneously, once a week

Also known as: Peginterferon alfa-2a
Pegasys

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Gomel Regional Clinical Hospital

Homyel, 246029, Belarus

Location

Vitebsk Regional Clinical Hospital

Vitebsk, 210037, Belarus

Location

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

Indore, 452001, India

Location

M V Hospital & Research Center

Lucknow, 226003, India

Location

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

Mumbai, 400007, India

Location

Medipoint Hospitals Pvt. Ltd.

Pune, 411007, India

Location

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

Moscow, 127473, Russia

Location

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

Moscow, Russia

Location

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

Moscow, Russia

Location

Federal State Budgetary Institution Research Institute of Influenza

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

LLC Medical Company "Hepatolog"

Samara, Russia

Location

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

Saratov, Russia

Location

Smolensk Regional Clinical Hospital

Smolensk, Russia

Location

State Budgetary Higher Vocational Education Institution Smolensk State Medical Academy

Smolensk, Russia

Location

State Budgetary Higher Vocational Education Institution Stavropol State Medical Academy

Stavropol, Russia

Location

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

Tyumen, Russia

Location

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

Bangkok, 10700, Thailand

Location

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

Chiang Mai, 50200, Thailand

Location

MeSH Terms

Conditions

HepatitisHepatitis C

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus Infections

Study Officials

  • Konstantin Zhdanov, Professor

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

    PRINCIPAL INVESTIGATOR

  • Olga Znoyko, Professor

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

    PRINCIPAL INVESTIGATOR

  • Marina Maevskaya, Professor

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

    PRINCIPAL INVESTIGATOR

  • Vjacheslav Morozov

    LLC Medical Company "Hepatolog", Samara, Russia

    PRINCIPAL INVESTIGATOR

  • Natalja Mironova, PhD

    Municipal Healthcare Institution City Clinical Hospital No.2 named after V.I. Razumovsky, Healthcare Committee at the Administration of "Saratov City" Municipal District

    PRINCIPAL INVESTIGATOR

  • Elena Nurmuhametova, PhD

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

    PRINCIPAL INVESTIGATOR

  • Victor Pasechnikov, Professor

    State Budgetary Higher Vocational Education Institution Stavropol State Medical Academy, Ministry of Health of the Russian Federation

    PRINCIPAL INVESTIGATOR

  • Natalia Petrochenkova, PhD

    State Budgetary Higher Vocational Education Institution Smolensk State Medical Academy

    PRINCIPAL INVESTIGATOR

  • Tamara Sologub, Professor

    Federal State Budgetary Institution Research Institute of Influenza, Ministry of Health of the Russian Federation, Saint-Petersburg

    PRINCIPAL INVESTIGATOR

  • Vladimir Rafalskiy, Professor

    Regional State Healthcare Institution "Smolensk Regional Clinical Hospital"

    PRINCIPAL INVESTIGATOR

  • Evgeniy Chesnokov, Professor

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

    PRINCIPAL INVESTIGATOR

  • Sandeep Gupta, Dr

    M V Hospital & Research Center, 314/30 Mirza Mandi, Chowk 226003, Lucknow 226003, Uttar Pradesh, India

    PRINCIPAL INVESTIGATOR

  • Tariq A Patil, Dr

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

    PRINCIPAL INVESTIGATOR

  • Mandar Doiphode, Dr

    Medipoint Hospitals Pvt. Ltd. Maharashtra, India

    PRINCIPAL INVESTIGATOR

  • G S Malpani, Dr

    Suyash Hospital Pvt. Ltd. Opposite M.G.M Medical College A.B. Road, Madhya Pradesh, India

    PRINCIPAL INVESTIGATOR

  • Tawesak Tanwandee

    Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Siriraj Hospital, Bangkoknoi, Bangkok, Thailand

    PRINCIPAL INVESTIGATOR

  • Thongsawat Satawat

    Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Sriphum, Muang, Chiang Mai, Thailand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2013

First Posted

June 28, 2013

Study Start

July 10, 2013

Primary Completion

December 2, 2015

Study Completion

December 2, 2015

Last Updated

July 16, 2018

Record last verified: 2018-07

Locations

IN(4)RU(11)BE(2)TH(2)