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Hepatitis C, ChronicPhase 4NCT00800748

A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis C

A Phase 4 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 35 sites in 2 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

This 3-arm study assessed the safety and efficacy of combination treatment with peginterferon alfa-2a + ribavirin in participants with chronic hepatitis C. Three groups of participants were studied; 1) those with elevated alanine transaminase (ALT) levels, 2) those with normal ALT levels, and 3) those with human… 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 and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
372 participants
Where
35 sitesin 2 countries
Study dates
1 Feb 2006to 9 Jan 2009
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants at least 18 years of age
  • Chronic hepatitis C, with detectable serum hepatitis C virus (HCV) ribonucleic acid (RNA)
  • Scheduled for treatment with peginterferon alfa-2a
  • Compensated liver disease
  • Women in fertile age must be informed about obligation of using adequate contraception during and 6 months post treatment with ribavirin (Copegus®)
  • Men with a sexual partner in fertile age must be informed about obligatory contraception preventing pregnancy during the course of treatment with ribavirin (Copegus®) as well as 6 months after treatment cessation
  • Female participants in the study must have a negative pregnancy test performed not sooner than within 2 weeks preceding the planned inclusion to the study
  • Men with a sexual partner in fertile age must produce a negative result of the partner's pregnancy test performed not sooner than within 2 weeks preceding the planned partner's inclusion to the study

Who cannot join

  • Chronic liver disease other than chronic hepatitis C
  • Active hepatitis A virus or hepatitis B virus infection
  • Therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment less than or equal to (<=) 6 months prior to first dose of study drug
  • Hemoglobin <120 grams per liter (g/L) in female participants or <130 g/L in male participants (the result must not be older than 2 weeks prior to inclusion to the study)
  • Platelet count <90 x 10^9/liter (the result must not be older than 2 weeks prior to inclusion to the study
  • Neutrofil count <1.5 x 10^9/liter (the result must not be older than 2 weeks prior to inclusion to the study)
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  • Participants with increased risk of anaemia, or participants at risk of serious health problems resulting from anaemia or decrease of hemoglobin (e.g., participants with serious cardiovascular or cerebrovascular disease)
  • History or presence of a serious mental disease, especially depression, which, in the investigator's opinion, does not allow administration of peginterferon alfa-2a (Pegasys®)
  • History or presence of a disease consequent to immunodeficiency (e.g., inflammatory diseases of intestine, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis)

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

Czechia28 sites

  • Study site

    Beroun

  • Study site

    Brno, 62500

  • Study site

    Česká Lípa

  • Study site

    České Budějovice, 370 87

  • Study site

    Chomutov

  • Study site

    Děčín, 0

  • Study site

    Havířov

  • Study site

    Havlíčkův Brod

  • Study site

    Hradec Králové, 500 12

  • Study site

    Hradec Králové

  • Study site

    Jablonec/nisou, 466 60

  • Study site

    Jihlava

  • Study site

    Karlovy Vary

  • Study site

    Kolín

  • Study site

    Liberec

  • Study site

    Mělník

  • Study site

    Most

  • Study site

    Olomouc

  • Study site

    Opava

  • Study site

    Ostrava, 708 52

  • Study site

    Pardubice

  • Study site

    Prague, 00000

  • Study site

    Prague, 128 08

  • Study site

    Prague, 140 00

  • Study site

    Prague, 180 01

  • Study site

    Prague

  • Study site

    Prostějov

  • Study site

    Ústí nad Labem

Other trials in Czechia

Slovakia7 sites

  • Study site

    Banská Bystrica, 957 17

  • Study site

    Bratislava, 833 05

  • Study site

    Bratislava, 851 07

  • Study site

    Košice, 040 01

  • Study site

    Košice, 04001

  • Study site

    Martin, 036 59

  • Study site

    Trenčín, 911 07

Other trials in Slovakia

About this study

Official title: An Open, Phase IV, Multicentric Study, Evaluating Safety and Efficacy of Ribavirin (Copegus®) and Peginterferon Alfa-2a (Pegasys®) Combination in Specific Groups

This 3-arm study assessed the safety and efficacy of combination treatment with peginterferon alfa-2a + ribavirin in participants with chronic hepatitis C. Three groups of participants were studied; 1) those with elevated alanine transaminase (ALT) levels, 2) those with normal ALT levels, and 3) those with human immunodeficiency virus (HIV) co-infection. Participants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) once weekly (qw) + ribavirin 1000-1200 milligrams (mg) orally (PO) daily (dependent on body weight) for 48 weeks. Those with genotype 2 or 3 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks, and all participants with HIV co-infection received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.

Being tested
Peginterferon alfa-2a, 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-2aDrug

    Also called Pegasys

    Peginterferon alfa-2a was administered at a dose of 180 mcg SC weekly for 48 weeks to participants with genotype 1, 4, 5, 6 and to participants with HIV co-infection, or for 24 weeks to participants with genotype 2 and 3.

  • RibavirinDrug

    Also called Copegus

    Ribavirin was administered at a dose of 1000-1200 mg PO daily for 48 weeks to participants with genotype 1, 4, 5, 6 or 800 mg PO daily for 24 weeks to participants with genotype 2 and 3.

Study groups in NCT00800748
Study groupRoleWhat they receive
Group AExperimentalParticipants with genotype 1, 4, 5 or 6 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 1000-1200 mg PO daily (dependent on body weight) for 48 weeks.
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin
Group BExperimentalParticipants with genotype 2 or 3 received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 24 weeks.
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin
Group CExperimentalParticipants with HIV co-infection received peginterferon alfa-2a 180 mcg SC qw + ribavirin 800 mg PO daily for 48 weeks.
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin

What is being measured

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

  1. Percentage of Participants With Sustained Virological Response

    Sustained virological response is defined as having no hepatitis C (HCV) virus detectable in the blood 24 weeks after end of treatment.

    Measured: Up to 72 weeks

Secondary outcomes (3)

  1. Percentage of Participants With End-of-Treatment Virological Response

    End-of-treatment virological response is defined as having no HCV virus detectable in the blood immediately after end of treatment.

    Measured: Up to 48 weeks

  2. Percentage of Participants With Early-Treatment Virological Response

    Early-treatment virological response is defined as having no HCV virus detectable in the blood or a 2-log (100-fold) decrease in HCV virus concentration in the blood after 12 weeks of study treatment.

    Measured: Up to 12 weeks

  3. Percentage of Participants With Adverse Events

    An adverse event is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsen during the study are reported as adverse events.

    Measured: Up to 72 weeks

Timeline

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

  1. First posted2 Dec 2008 (estimated)
  2. Study start1 Feb 2006
  3. Primary completion9 Jan 2009
  4. Study completion9 Jan 2009

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00800748
Sponsor's protocol ID
ML19387
Other IDs
2005-003932-23, 2005
Status last verified
May 2017
First submitted
1 Dec 2008
Last updated
22 May 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 35 sites in 2 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 9 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 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Czechia, Slovakia. 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?

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?

Percentage of Participants With Sustained Virological Response (time frame: Up to 72 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 NCT00800748.

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 22 May 2017.

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