Hepatitis D, ChronicPhase 3NCT02732639
A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
A Phase 3 study testing Pegylated Interferon (PEG-IFN) alfa-2a in people with Hepatitis D, Chronic, run by Hoffmann-La Roche at 7 sites in Romania.
Trial summary
This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis D, Chronic
- What is being tested?
- Pegylated Interferon (PEG-IFN) alfa-2a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 7 sitesRomania
- Study dates
- Oct 2005to Dec 2008
- Phase
- Phase 3
- 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
- Positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to screening
- Positive anti-delta for at least 3 months prior to screening
- Positive hepatitis D virus (HDV) ribonucleic acid (RNA)
- A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30 months for cirrhotic patients demonstrating liver disease consistent with chronic hepatitis D (CHD)
- Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug
Who cannot join
- Antiviral therapy for CHD within the previous 6 months
- Positive hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
- Evidence of decompensated liver disease
- Other medical condition associated with chronic liver disease
- Women with ongoing pregnancy or who are breast feeding
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Romania7 sites
Study site
Bucharest, 021105
Study site
Bucharest, 022328
Study site
Cluj-Napoca, 400162
Study site
Constanța
Study site
Craiova
Study site
Iași, 700111
Study site
Timișoara, 293406
About this study
Official title: Open-label, Multicenter, Trial Evaluating Efficacy and Safety of Peginterferon Alfa-2a (PEGASYS®) in Patients With Chronic Hepatitis D (CHD)
This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.
- Conditions
- Hepatitis D, Chronic
- Being tested
- Pegylated Interferon (PEG-IFN) alfa-2a
- Medical subject headings
- Hepatitis D, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegylated Interferon (PEG-IFN) alfa-2aDrug
Also called PEGASYS
Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pegylated Interferon (PEG-IFN) alfa-2a | Experimental | Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up. Receives: Drug: Pegylated Interferon (PEG-IFN) alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72
Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.
Measured: At Week 72
Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
Measured: At Week 72
Secondary outcomes (6)
Percentage of Participants With Normal ALT at Week 48
Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay.
Measured: At Week 48
Percentage of Participants With Negative HDV RNA at Week 48
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
Measured: At Week 48
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72
Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1*10^5 copies/mL.
Measured: At Weeks 48 and 72
Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels
Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay.
Measured: At Screening and at Weeks 48 and 72
Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72
Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay.
Measured: At Weeks 48 and 72
Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72
Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg.
Measured: At Weeks 48 and 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startOct 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis D, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732639
- Sponsor's protocol ID
- ML18788
- Status last verified
- Jul 2016
- First submitted
- 5 Apr 2016
- Last updated
- 26 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Trial Evaluating Efficacy and Safety of Peginterferon Alfa-2a (PEGASYS®) in Patients With Chronic Hepatitis D (CHD)
- ClinicalTrials.gov ID
- NCT02732639
- Acronym / sponsor ID
- ML18788
- Conditions
- Hepatitis D, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Posted 26 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegylated Interferon (PEG-IFN) alfa-2a | Experimental | Drug: Pegylated Interferon (PEG-IFN) alfa-2aParticipants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to screening
- Positive anti-delta for at least 3 months prior to screening
- Positive hepatitis D virus (HDV) ribonucleic acid (RNA)
- A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30 months for cirrhotic patients demonstrating liver disease consistent with chronic hepatitis D (CHD)
- Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug
Key exclusion criteria (5 listed)
- Antiviral therapy for CHD within the previous 6 months
- Positive hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
- Evidence of decompensated liver disease
- Other medical condition associated with chronic liver disease
- Women with ongoing pregnancy or who are breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pegylated Interferon (PEG-IFN) alfa-2aAlso: PEGASYSParticipants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks. | Drug | Pegylated Interferon (PEG-IFN) alfa-2a |
Primary outcome
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72
Time frame: At Week 72
Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.
Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72
Time frame: At Week 72
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
6 secondary outcomes
Percentage of Participants With Normal ALT at Week 48
Time frame: At Week 48
Percentage of Participants With Negative HDV RNA at Week 48
Time frame: At Week 48
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72
Time frame: At Weeks 48 and 72
Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels
Time frame: At Screening and at Weeks 48 and 72
Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72
Time frame: At Weeks 48 and 72
Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72
Time frame: At Weeks 48 and 72
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study chair
Hoffmann-La Roche
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pegylated Interferon (PEG-IFN) alfa-2a in people with Hepatitis D, Chronic, run by Hoffmann-La Roche at 7 sites in Romania.
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 5 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 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Romania. 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?
Yes. Results are posted in the registry (first posted 26 Aug 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?
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 (time frame: At Week 72). 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?
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 26 Aug 2016.