AzTrials
AzTrials

Hepatitis C, ChronicPhase 4NCT00922779

A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C

A Phase 4 study testing peginterferon alfa-2a [Pegasys] and ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 93 sites in Russia.

Completed

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

Official record
Search all trials

Trial summary

This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (< and >75kg)in combination with PEGASYS 180micrograms sc weekly. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
peginterferon alfa-2a [Pegasys] and ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,661 participants
Where
93 sitesRussia
Study dates
Jun 2002to Jun 2012
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients, >=18 years of age;
  • serological evidence of chronic hepatitis C;
  • detectable serum HCV-RNA;
  • liver biopsy findings consistent with a diagnosis of chronic hepatitis C.

Who cannot join

  • history or other evidence of a medical condition associated with chronic liver disease other than HCV;
  • co-infection with active hepatitis A or B;
  • hepatocellular carcinoma;
  • patients with severe cardiovascular disease whose condition may worsen due to acute anemia.

Trial locations and contacts

93 sites in 1 country.

93 sites in 1 country

Russia93 sites

  • Study site

    Arkhangelsk, 163000

  • Study site

    Barnaul, 656010

  • Study site

    Barnaul, 656045

  • Study site

    Blagoveshchensk, 675007

  • Study site

    Cheboksary, 428016

  • Study site

    Chelyabinsk, 454048

  • Study site

    Chelyabinsk, 454052

  • Study site

    Chelyabinsk, 454071

  • Study site

    Cherepovets, 162600

  • Study site

    Chita, 672090

  • Study site

    Irkutsk, 664043

  • Study site

    Irkutsk, 664047

  • Study site

    Irkutsk, 664079

  • Study site

    Izhevsk, 426067

  • Study site

    Kazan', 420097

  • Study site

    Kemerovo, 650000

  • Study site

    Kemerovo, 650036

  • Study site

    Kemerovo, 650099

  • Study site

    Khabarovsk, 680009

  • Study site

    Khabarovsk, 680022

  • Study site

    Khabarovsk, 680031

  • Study site

    Kirov, 610000

  • Study site

    Krasnodar, 350012

  • Study site

    Krasnodar, 350015

  • Study site

    Krasnodar, 350086

  • Study site

    Krasnoyarsk, 660022

  • Study site

    Krasnoyarsk, 660049

  • Study site

    Lipetsk, 398043

  • Study site

    Makhachkala, 367008

  • Study site

    Moscow, 103875

  • Study site

    Moscow, 105203

  • Study site

    Moscow, 109325

  • Study site

    Moscow, 111020

  • Study site

    Moscow, 111123

  • Study site

    Moscow, 115201

  • Study site

    Moscow, 115446

  • Study site

    Moscow, 115516

  • Study site

    Moscow, 115682

  • Study site

    Moscow, 119002

  • Study site

    Moscow, 119881

  • Study site

    Moscow, 121293

  • Study site

    Moscow, 123098

  • Study site

    Moscow, 123367

  • Study site

    Moscow, 125101

  • Study site

    Moscow, 125367

  • Study site

    Moscow, 127247

  • Study site

    Moscow, 129110

  • Study site

    Moscow, 143420

  • Study site

    Moscow

  • Study site

    Nizhny Novgorod, 603022

  • Study site

    Novokuznetsk, 654018

  • Study site

    Novokuznetsk, 654029

  • Study site

    Novosibirsk, 630016

  • Study site

    Novoural'sk, 624130

  • Study site

    Omsk, 644010

  • Study site

    Orenburg, 460035

  • Study site

    Petropavlovsk-Kamchatskiy, 683003

  • Study site

    Rostov-on-Don, 344022

  • Study site

    Saint Petersburg, 191167

  • Study site

    Saint Petersburg, 194044

  • Study site

    Saint Petersburg, 194291

  • Study site

    Saint Petersburg, 195067

  • Study site

    Saint Petersburg, 195275

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saint Petersburg, 198103

  • Study site

    Saint Petersburg, 199034

  • Study site

    Salekhard, 629001

  • Study site

    Samara, 443011

  • Study site

    Samara, 443021

  • Study site

    Saratov, 410026

  • Study site

    Saratov, 410028

  • Study site

    Saratov, 410040

  • Study site

    Sashi, 354057

  • Study site

    Stavropol, 355017

  • Study site

    Surgut, 628400

  • Study site

    Tomsk, 634050

  • Study site

    Tyumen, 625002

  • Study site

    Tyumen, 625017

  • Study site

    Tyumen, 625026

  • Study site

    Tyumen, 629806

  • Study site

    Ufa, 450000

  • Study site

    Ufa, 450005

  • Study site

    Ulan-Ude, 670042

  • Study site

    Vladivostok, 690011

  • Study site

    Vladivostok, 690065

  • Study site

    Volgograd, 400040

  • Study site

    Volgograd, 400138

  • Study site

    Yakutsk, 677000

  • Study site

    Yekaterinburg, 620020

  • Study site

    Yekaterinburg, 620042

  • Study site

    Yekaterinburg, 620102

  • Study site

    Yujno-sakhalinsk, 690000

  • Study site

    Yujno-sakhalinsk, 693000

Other trials in Russia

About this study

Official title: Safety and Tolerability of Ribavirin (RO 20-9963) in Combination With Peginterferon Alfa-2a (40 kD)in Patients With Chronic Hepatitis C

This single arm study will evaluate the safety and tolerability of ribavirin in combination with PEGASYS in patients with chronic hepatitis C. Patients will receive ribavirin 800mg, or 1000-1200mg po daily, according to HCV genotype and body weight (< and >75kg)in combination with PEGASYS 180micrograms sc weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

Being tested
peginterferon alfa-2a [Pegasys], ribavirin
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • peginterferon alfa-2a [Pegasys]Drug

    180micrograms sc weekly for 12-48 weeks

  • ribavirinDrug

    800mg, or 1000-1200mg, po daily (dependent on HCV genotype and body weight)

Study groups in NCT00922779
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin

What is being measured

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

  1. Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs.

    Measured: From signing of informed consent up to end of study (up to Week 72)

Secondary outcomes (3)

  1. Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy

    SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as [number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy.

    Measured: 24 weeks after end of therapy (Week 72)

  2. Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation

    HCV RNA levels of < 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as [number of participants with undetectable HCV RNA divided by the total number of participants analyzed] multiplied by 100 for Weeks 12, 24 and 48.

    Measured: Weeks 12,24 and 48 After Therapy Initiation

  3. Percentage of Participants With Change in Hemoglobin Level

    Change in hemoglobin level (compared to baseline) was reported as "significant decrease", "Normal" (no change), "Increase", "Decrease", and "Missing". Significant decrease was defined as per Investigator's discretion.

    Measured: Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72)

Timeline

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

  1. First posted17 Jun 2009 (estimated)
  2. Study startJun 2002
  3. Primary completionJun 2012
  4. Study completionJun 2012

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6,661 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00922779
Sponsor's protocol ID
ML16709
Status last verified
Dec 2015
First submitted
16 Jun 2009
Last updated
20 Jan 2016

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing peginterferon alfa-2a [Pegasys] and ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 93 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 4 inclusion and 4 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 20 Jan 2016). 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 Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) (time frame: From signing of informed consent up to end of study (up to Week 72)). 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 NCT00922779.

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 20 Jan 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in