Trial · NCT02765802
A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection
NCT02765802, Phase 2, Completed, EIT Pharma, Inc.; results first posted 2023-01-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection. Trials, record NCT02765802. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02765802
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection
- NCT number
- NCT02765802
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 33 participants, actual
- Lead sponsor
- EIT Pharma, Inc.
- Conditions
- Hepatitis D, Chronic
- Interventions
- Peginterferon Lambda-1A
- First posted
- 2016-05-09
- Last updated
- 2026-09-08
- Results first posted
- 2023-01-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in HDV Viral Load. | Week 48 (end of treatment) | To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a 48 week treatment period. To evaluate the effect of treatment with 2 different doses of Lambda on hepatitis D virus (HDV) ribonucleic acid (RNA) levels. |
| Secondary | Change From Baseline in HDV Viral Load | Week 72 (end of follow-up) | To evaluate the proportion of patients with undetectable HDV RNA 24 weeks after the end of treatment |
| Secondary | Number of Patients With a Durable Virologic Response | Week 72 | Durable Virologic Response (DVR) = below the limit of quantitation in HDV RNA at 24 weeks post-treatment |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in HDV Viral Load. | Week 48 (end of treatment) | Change in HDV RNA log IU/mL | MEAN | |
| SECONDARY | Change From Baseline in HDV Viral Load | Week 72 (end of follow-up) | Change in HDV RNA log IU/mL | MEAN | |
| SECONDARY | Number of Patients With a Durable Virologic Response | Week 72 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in HDV Viral Load. | Lambda 180 μg | -2.14 | Standard Deviation 1.81 | Change in HDV RNA log IU/mL | |
| Change From Baseline in HDV Viral Load. | Lambda 120 μg | -1.16 | Standard Deviation 2.38 | Change in HDV RNA log IU/mL | |
| Change From Baseline in HDV Viral Load | Lambda 180 μg | -1.70 | Standard Deviation 1.70 | Change in HDV RNA log IU/mL | |
| Change From Baseline in HDV Viral Load | Lambda 120 μg | -0.66 | Standard Deviation 1.57 | Change in HDV RNA log IU/mL | |
| Number of Patients With a Durable Virologic Response | Peginterferon Lambda-1A 180 μg | 5 | Participants | ||
| Number of Patients With a Durable Virologic Response | Peginterferon Lambda-1A 120 μg | 3 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lambda 180 μg | 14 | |
| Overall Study | STARTED | Lambda 120 μg | 19 | |
| Overall Study | COMPLETED | Lambda 180 μg | 14 | |
| Overall Study | COMPLETED | Lambda 120 μg | 19 | |
| Overall Study | NOT COMPLETED | Lambda 180 μg | 0 | |
| Overall Study | NOT COMPLETED | Lambda 120 μg | 0 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Jaundice | Hepatobiliary disorders | Lambda 180 μg | 2 | 14 | |
| other | Jaundice | Hepatobiliary disorders | Lambda 120 μg | 4 | 19 | |
| other | Alanine Aminotransferase (ALT) increase | Investigations | Lambda 180 μg | 5 | 14 | |
| other | Alanine Aminotransferase (ALT) increase | Investigations | Lambda 120 μg | 3 | 19 | |
| other | Aspartate Aminotransferase (AST) Increase | Investigations | Lambda 180 μg | 5 | 14 | |
| other | Aspartate Aminotransferase (AST) Increase | Investigations | Lambda 120 μg | 2 | 19 | |
| other | Blood bilirubin increased | Investigations | Lambda 180 μg | 4 | 14 | |
| other | Blood bilirubin increased | Investigations | Lambda 120 μg | 2 | 19 | |
| other | gamma-glutamyl transferase (GGT) increased | Investigations | Lambda 180 μg | 2 | 14 | |
| other | gamma-glutamyl transferase (GGT) increased | Investigations | Lambda 120 μg | 2 | 19 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lambda 180 μg | 0 | 14 |
| Total, all-cause mortality | Lambda 120 μg | 0 | 19 |
| Total, other adverse events | Lambda 180 μg | 14 | 14 |
| Total, other adverse events | Lambda 120 μg | 19 | 19 |
| Total, serious adverse events | Lambda 180 μg | 2 | 14 |
| Total, serious adverse events | Lambda 120 μg | 5 | 19 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Peginterferon Lambda-1A 180 μg vs Peginterferon Lambda-1A 120 μg: Number of Patients With a Durable Virologic Response | Trial comparisons |
| Lambda 180 μg vs Lambda 120 μg: deaths from any cause | Trial comparisons |
| Lambda 180 μg vs Lambda 120 μg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02765802
GET https://conductscience.org/api/trials/v1/NCT02765802/events?page=2