AzTrials
AzTrials

Hepatitis B, ChronicPhase 4NCT02570191

A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)

A Phase 4 study testing Peginterferon alfa-2a in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 8 sites in Bulgaria.

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 study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
Peginterferon alfa-2a
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
8 sitesBulgaria
Study dates
Nov 2004to Feb 2007
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants 18-70 years of age
  • Positive test result for HBsAg for >6 months
  • Naive to treatment for HBV
  • On liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis

Who cannot join

  • Co-infection with hepatitis A, C or D, or with Human Immunodeficiency Virus (HIV)
  • Decompensated liver disease
  • Hepatocellular cancer
  • Systemic anti-viral, anti-neoplastic, or immunomodulatory therapy less than or equal to 6 months before study drug
  • Medical condition associated with chronic liver disease

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Bulgaria8 sites

  • Study site

    Pleven, 5800

  • Study site

    Plovdiv, 4002

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1431

  • Study site

    Sofia, 1527

  • Study site

    Sofia, 1606

  • Study site

    Sofia, 1612

  • Study site

    Stara Zagora, 6000

Other trials in Bulgaria

About this study

Official title: An Open-label, Multicenter, National, Not-randomized Study to Evaluate Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (PEGASYS) in Patients With HBeAg-negative Chronic Hepatitis B

This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.

Being tested
Peginterferon alfa-2a
Medical subject headings
Hepatitis B, 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

    180 uG in 0.5 mL solution administered once weekly for 48 weeks

Study groups in NCT02570191
Study groupRoleWhat they receive
Peginterferon alfa-2aExperimentalParticipants received 180 micrograms (uG) of Pegasys (0.5 milliliter [mL] solution) once a week subcutaneously for 48 weeks.
Receives: Drug: Peginterferon alfa-2a

What is being measured

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

  1. Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up

    Measured: 72 Weeks

  2. Alanine Transaminase (ALT) Normalization at the End of Follow-Up

    Measured: 72 Weeks

Secondary outcomes (4)

  1. Efficacy: Loss of Hepatitis B Virus Antigen ( HBsAg) and Seroconversion at End of Follow-Up

    Measured: 72 Weeks

  2. Hepatitis B Virus (HBV) DNA Below the Limit of Quantification At the End of Follow-Up

    Measured: 72 Weeks

  3. HBV DNA Suppression <20000 Copies/mL at the End of Treatment

    Measured: 48 Weeks

  4. Alanine Transaminase (ALT) Normalization at the End of Treatment

    Measured: 48 Weeks

Timeline

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

  1. First posted7 Oct 2015 (estimated)
  2. Study startNov 2004
  3. Primary completionFeb 2007
  4. Study completionFeb 2007

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
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02570191
Sponsor's protocol ID
ML18092
Status last verified
Nov 2016
First submitted
5 Oct 2015
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Peginterferon alfa-2a in people with Hepatitis B, Chronic, run by Hoffmann-La Roche at 8 sites in Bulgaria.

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 5 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Bulgaria. 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?

Efficacy: Hepatitis B Virus - Deoxy ribonucleic acid (HBV-DNA) less than (<)20,000 Copies per milliliter (copies/mL) At End of Follow-Up (time frame: 72 Weeks). The study lists 2 primary outcomes in all. 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 NCT02570191.

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 2 Nov 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