Hepatitis D, ChronicPhase 2NCT02731131
A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)
A Phase 2 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis D, Chronic, run by Hoffmann-La Roche at 1 site in Italy.
Trial summary
This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD. 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?
- Peginterferon alfa-2a and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2004to May 2009
- Phase
- Phase 2
- 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 the prior 6 months
- Positive anti-delta for the prior 3 months
- Positive HDV RNA at Screening
- Elevated ALT (1 to 10 times upper limit of normal) prior to first dose
- Chronic, necroinflammatory hepatitis documented within the prior 18 months (non-cirrhotic) or 30 months (cirrhotic)
- Negative pregnancy and adequate contraceptive use
Who cannot join
- Antiviral therapy for CHD within previous 3 months
- Positive for hepatitis A or C, or human immunodeficiency virus (HIV)
- Increased risk of metabolic liver disease
- Decompensated liver disease
- Elevated bilirubin
- Poor hematologic or renal function
Show all 11Show fewer
- Drug/alcohol abuse within 1 year prior to study
- History of significant psychiatric, autoimmune, pulmonary, cardiac, oncologic, or thyroid disease
- Organ transplantation with existing functional graft
- Retinopathy or other ophthalmologic complication of diabetes or hypertension
- Inclusion in another investigational trial within previous 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Pilot, Open-Label, Monocenter, Efficacy and Safety Study Examining the Effects of Peginterferon Alfa-2a (Pegasys) With or Without Ribavirin (Copegus) in Patients With Chronic Hepatitis D
This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.
- Conditions
- Hepatitis D, Chronic
- Being tested
- Peginterferon alfa-2a, Ribavirin
- 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.
Peginterferon alfa-2aDrug
Also called Pegasys
Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
RibavirinDrug
Also called Copegus
Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Monotherapy with Peginterferon alfa-2a | Experimental | Participants will receive peginterferon alfa-2a alone, administered over 48 weeks. Receives: Drug: Peginterferon alfa-2a |
| Group B: Combination with Peginterferon alfa-2a + Ribavirin | Experimental | Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 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.
Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment
Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.
Measured: Week 96
Secondary outcomes (5)
Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment
Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported.
Measured: Week 48
Number of Participants With ALT Normalization at 48 Weeks After End of Treatment
Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported.
Measured: Week 96
Number of Participants With ALT Normalization at End of Treatment
Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported.
Measured: Week 48
Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment
Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported.
Measured: Week 96
Number of Participants With Negative HDV RNA at End of Treatment
Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported.
Measured: Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startSep 2004
- Primary completionMay 2009
- Study completionMay 2009
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02731131
- Sponsor's protocol ID
- ML18149
- Status last verified
- Jun 2016
- First submitted
- 1 Apr 2016
- Last updated
- 15 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Pilot, Open-Label, Monocenter, Efficacy and Safety Study Examining the Effects of Peginterferon Alfa-2a (Pegasys) With or Without Ribavirin (Copegus) in Patients With Chronic Hepatitis D
- ClinicalTrials.gov ID
- NCT02731131
- Acronym / sponsor ID
- ML18149
- Conditions
- Hepatitis D, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Posted 15 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Monotherapy with Peginterferon alfa-2a | Experimental | Drug: Peginterferon alfa-2aParticipants will receive peginterferon alfa-2a alone, administered over 48 weeks. |
| Group B: Combination with Peginterferon alfa-2a + Ribavirin | Experimental | Drug: Peginterferon alfa-2a, Drug: RibavirinParticipants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Positive hepatitis B surface antigen (HBsAg) for the prior 6 months
- Positive anti-delta for the prior 3 months
- Positive HDV RNA at Screening
- Elevated ALT (1 to 10 times upper limit of normal) prior to first dose
- Chronic, necroinflammatory hepatitis documented within the prior 18 months (non-cirrhotic) or 30 months (cirrhotic)
Key exclusion criteria (11 listed)
- Antiviral therapy for CHD within previous 3 months
- Positive for hepatitis A or C, or human immunodeficiency virus (HIV)
- Increased risk of metabolic liver disease
- Decompensated liver disease
- Elevated bilirubin
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 |
|---|---|---|
| Peginterferon alfa-2aAlso: PegasysPeginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection. | Drug | Group A: Monotherapy with Peginterferon alfa-2a, Group B: Combination with Peginterferon alfa-2a + Ribavirin |
| RibavirinAlso: CopegusRibavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses. | Drug | Group B: Combination with Peginterferon alfa-2a + Ribavirin |
Primary outcome
Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment
Time frame: Week 96
Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.
5 secondary outcomes
Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment
Time frame: Week 48
Number of Participants With ALT Normalization at 48 Weeks After End of Treatment
Time frame: Week 96
Number of Participants With ALT Normalization at End of Treatment
Time frame: Week 48
Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment
Time frame: Week 96
Number of Participants With Negative HDV RNA at End of Treatment
Time frame: Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis D, Chronic, run by Hoffmann-La Roche at 1 site in Italy.
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 6 inclusion and 11 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 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Jul 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 Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment (time frame: Week 96). 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 15 Jul 2016.