Hepatitis D, ChronicPhase 3NCT00686790

Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)

A Phase 3 study testing Peginterferon alfa-2b (PegIntron, SCH 54031) in people with Hepatitis D, Chronic and Hepatitis B, Chronic, run by Merck Sharp & Dohme LLC.

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

The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus B and D. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hepatitis D, Chronic, Hepatitis B, Chronic
What is being tested?: Peginterferon alfa-2b (PegIntron, SCH 54031)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: No sites listed yet
Study dates: Dec 2005to May 2009
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
Age 18-65 years old.
HBsAg positive >6 months.
ALT >= 2 ULN >6 months.
HDV RNA positive serology.
Serum antibody to hepatitis delta antigen of IgG and IgM class.

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Knodell score HAI >= 6 and F >= 0; positive test for intrahepatic Delta antigen in liver biopsy.
Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
Participants must be free of any clinically significant disease (other than chronic hepatitis B and D), that would interfere with study evaluations.
Participants must understand and be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.

Who cannot join

Age <18 and >65.
Concomitant HCV and/or HIV infection.
Actual liver failure (total serum bilirubin >2.5 x normal, prolonged prothrombin time >3 sec, serum albumin <3 g/dl, history of ascites, variceal bleeding, or hepatic encephalopathy).
Toxic or autoimmune hepatitis (ANA titers > 1:160), metabolic liver diseases (Wilson disease, hemochromatosis, α-1 antitrypsin deficiency)
Women who are pregnant or nursing.
Leukopenia (<2500/mm^3), neutropenia (<1000/mm^3), hemoglobin <10 g/dl, presence of other severe diseases (myocardiopathy, diabetes mellitus, arterial hypertension, neoplasia, neurologic diseases, malnutrition).
Antiviral, immunomodulatory, corticosteroid, or chemotherapeutical treatment within 6 months of the participation in the study.
Depression and/or psychiatric disorders.

About this study

Official title: An Open Label, Uncontrolled, Study to Assess the Response of Peg-Intron in naïve Patients With Chronic Hepatitis B and D Co-infection

Conditions: Hepatitis D, Chronic, Hepatitis B, Chronic
Being tested: Peginterferon alfa-2b (PegIntron, SCH 54031)
Keywords: Hepatitis D, Hepatitis B
Medical subject headings: Hepatitis D, Chronic, Hepatitis B, Chronic, Hepatitis D, Hepatitis B

What participants receive

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

Peginterferon alfa-2b (PegIntron, SCH 54031)Biological
Also called SCH 54031, PegIntron
Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks.

Study groups in NCT00686790
Study group	Role	What they receive
PegIntron	Experimental	All participants received PegIntron (Peginterferon alfa-2b) weekly based on their body weight. Receives: Biological: Peginterferon alfa-2b (PegIntron, SCH 54031)

What is being measured

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

Number of Participants With a Virological Response
For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT).
Measured: 52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation
Number of Participants With a Biochemical Response
A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L.
Measured: 52 weeks (EOT), 104 weeks (EOF)
Number of Participants With a Combined Response
The combined response was defined as an ALT level below the upper
reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L.
Measured: 52 weeks (EOT), 104 weeks (EOF)

Secondary outcomes (2)

Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response)
Serum samples collected from the participants were tested by PCR to detect HBV-DNA. HBV response was defined as the absence of HBV-deoxyribonucleic acid (HBV-DNA) in serum.
Measured: 52 week (EOT)
Number of Participants With a Liver Histology Response
The liver histology response was defined as at least a 2 point decrease in the necrosis inflammation score (a sum of periportal necrosis [0-10], lobular inflammation [0-4], portal inflammation [0-4], with the total score of 18 representing the worst outcome) and no increase or regression of fibrosis (scored [0-4]) in the pre- and post-treatment liver biopsies.
The efficacy of treatment based on histological response was assessed by the investigator as complete response, partial response, minimal response, progressive disease, and not assessable at EOT.
Measured: Baseline and 52 week (EOT)

Timeline

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

Dec 2005May 2009

First posted30 May 2008 (estimated)
Study startDec 2005
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 Merck Sharp & Dohme LLCThe 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: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00686790
Sponsor's protocol ID: P04603
Status last verified: Mar 2017
First submitted: 27 May 2008
Last updated: 6 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Uncontrolled, Study to Assess the Response of Peg-Intron in naïve Patients With Chronic Hepatitis B and D Co-infection
ClinicalTrials.gov ID: NCT00686790
Acronym / sponsor ID: P04603
Conditions: Hepatitis D, Chronic, Hepatitis B, Chronic
Keywords: Hepatitis D, Hepatitis B
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2005
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 30 May 2008 (estimated)
Results: Posted 17 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PegIntron	Experimental	Biological: Peginterferon alfa-2b (PegIntron, SCH 54031)All participants received PegIntron (Peginterferon alfa-2b) weekly based on their body weight.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Participants must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
Age 18-65 years old.
HBsAg positive >6 months.
ALT >= 2 ULN >6 months.
HDV RNA positive serology.

Key exclusion criteria (8 listed)

Age <18 and >65.
Concomitant HCV and/or HIV infection.
Actual liver failure (total serum bilirubin >2.5 x normal, prolonged prothrombin time >3 sec, serum albumin <3 g/dl, history of ascites, variceal bleeding, or hepatic encephalopathy).
Toxic or autoimmune hepatitis (ANA titers > 1:160), metabolic liver diseases (Wilson disease, hemochromatosis, α-1 antitrypsin deficiency)
Women who are pregnant or nursing.

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-2b (PegIntron, SCH 54031)Also: SCH 54031, PegIntronPeginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks.	Biological	PegIntron

Primary outcome

Number of Participants With a Virological Response
Time frame: 52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation
For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT).
Number of Participants With a Biochemical Response
Time frame: 52 weeks (EOT), 104 weeks (EOF)
A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L.
Number of Participants With a Combined Response
Time frame: 52 weeks (EOT), 104 weeks (EOF)
The combined response was defined as an ALT level below the upper reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L.

2 secondary outcomes

Number of Participants With Hepatitis B Virus (HBV) Replication Response (HBV Response)
Time frame: 52 week (EOT)
Number of Participants With a Liver Histology Response
Time frame: Baseline and 52 week (EOT)

Results and safety

Results posted to the registry on 17 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PegIntron	48	32

Primary outcome: Number of Participants With a Virological Response

Time frame: 52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation. Number. Unit: Participants

Measure	PegIntron n = 36
Responders at 52 weeks	12
Non-responders at 52 weeks	24
Responders at 104 weeks	9
Non-responders at 104 weeks	27

Population analysed: The population analyzed excludes participants that were not administered any study medication and had protocol violations. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.

Primary outcome: Number of Participants With a Biochemical Response

Time frame: 52 weeks (EOT), 104 weeks (EOF). Number. Unit: Participants

Measure	PegIntron n = 32
Responders at 52 weeks	18
Non-responders at 52 weeks	14
Responders at 104 weeks	9
Non-responders at 104 weeks	23

Population analysed: The population analyzed excluded participants that were not administered study medication, had protocol violations and those for whom ALT values were not available. 2 participants with adverse events (AE) that had protocol violations have been included in the analysis.

Primary outcome: Number of Participants With a Combined Response

Time frame: 52 weeks (EOT), 104 weeks (EOF). Number. Unit: Participants

Measure	PegIntron n = 32
Responders at 52 weeks	7
Non-responders at 52 weeks	25
Responders at 104 weeks	6
Non-responders at 104 weeks	26

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PegIntron	3 of 49 (6.1%)	47 of 49 (95.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Peginterferon alfa-2b (PegIntron, SCH 54031) in people with Hepatitis D, Chronic and Hepatitis B, Chronic, run by Merck Sharp & Dohme LLC.

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 10 inclusion and 8 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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

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 17 Jan 2011). 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 a Virological Response (time frame: 52 weeks (end of treatment [EOT]), 104 weeks (end of follow-up [EOF]) following treatment initiation). The study lists 3 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 NCT00686790.

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 6 Apr 2017.