National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Who can join
Adults 18 to 80, any sex, with Chronic Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Interferon-stimulated-gene (ISG) ExpressionPrimary· 6 hours after first injection of peginterferon
Change in level of ISG expression before and after 1st peginterferon injection
PPP1R3G
Group
Value
95% CI
HBeAg Negative
-2.716
± 0.628
ALAS1
Group
Value
95% CI
HBeAg Negative
1.670
± 0.416
INHBB
Group
Value
95% CI
HBeAg Negative
-2.20
± 0.570
MMRN1
Group
Value
95% CI
HBeAg Negative
-1.597
± 0.432
LYVE1
Group
Value
95% CI
HBeAg Negative
-1.184
± 0.326
SLC8A1
Group
Value
95% CI
HBeAg Negative
-1.382
± 0.386
PPARGC1A
Group
Value
95% CI
HBeAg Negative
-1.573
± 0.443
NOTUM
Group
Value
95% CI
HBeAg Negative
0.870
± 0.250
Hepatitis B e Antigen (HBeAg) LossSecondary· End of treatment, 24 weeks, and 48 weeks
Proportion of HBeAg positive patients showing eAg loss at end of treatment, and 24 and 48 weeks off peginterferon treatment.
End of treatment
Group
Value
95% CI
HBeAg Positive
0
Week 24 post treatment
Group
Value
95% CI
HBeAg Positive
0
Week 48 post treatment
Group
Value
95% CI
HBeAg Positive
0
Hepatitis B s Antigen (HBsAg) LossSecondary· End of treatment, 24 weeks, and 48 weeks
Proportion of HBsAg positive patients showing sAG loss at end of treatment and 24 and 48 weeks off peginterferon treatment
End of treatment
Group
Value
95% CI
HBeAg Positive
0
HBeAg Negative
1
Week 24 post treatment
Group
Value
95% CI
HBeAg Positive
0
HBeAg Negative
0
Week 48 post treatment
Group
Value
95% CI
HBeAg Positive
0
HBeAg Negative
0
Change in Natural Killer (NK) Cell FrequencySecondary· 6 hours after first injection of peginterferon and baseline
NK cell frequency is calculated as 100\*(NK cells)/(mononuclear cells). Changes are calculated by subtracting baseline from 6 hours after first peginterferon injection.
Blood baseline
Group
Value
95% CI
HBeAg Positive
15.60
± NA
HBeAg Negative
11.82
± 10.19
Blood 6 hours
Group
Value
95% CI
HBeAg Positive
10.30
± NA
HBeAg Negative
13.74
± 10.68
Blood change
Group
Value
95% CI
HBeAg Positive
-5.3
± NA
HBeAg Negative
1.92
± 7.48
Liver baseline
Group
Value
95% CI
HBeAg Negative
24.69
± 6.26
Liver 6 hours
Group
Value
95% CI
HBeAg Negative
24.78
± 7.28
Liver change
Group
Value
95% CI
HBeAg Negative
0.09
± 4.08
Change in Natural Killer (NK) Cell DegranulationSecondary· 6 hours after first injection of peginterferon and baseline
NK cell degranulation is calculated as 100\*(degranulated NK cells)/(NK cells). Changes are calculated by subtracting baseline from 6 hours after first peginterferon injection.
Blood baseline
Group
Value
95% CI
HBeAg Positive
0.08
± NA
HBeAg Negative
0.64
± 0.65
Blood 6 hours
Group
Value
95% CI
HBeAg Positive
0.06
± NA
HBeAg Negative
0.52
± 0.66
Blood change
Group
Value
95% CI
HBeAg Positive
-0.02
± NA
HBeAg Negative
-0.12
± 0.93
Liver baseline
Group
Value
95% CI
HBeAg Negative
3.37
± 1.46
Liver 6 hours
Group
Value
95% CI
HBeAg Negative
4.87
± 4.47
Liver change
Group
Value
95% CI
HBeAg Negative
1.51
± 5.08
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected over three periods encompassing a total of 50 to 60 weeks. The first period was up to twelve weeks, from pre-treatment biopsy to start of peginterferon treatment. The second period was 24 weeks during treatment with peginterferon, and the third period was after completion of treatment with peginterferon..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Background:
\- Chronic hepatitis B is caused by a virus that infects the liver. Cure is not possible but the virus can be controlled with the use of antiviral medicines,. Researchers think that adding a second antiviral medicine might help.
Objective:
\- To understand how peginterferon might help treat people with chronic hepatitis B. Also, to see if peginterferon is safe to use with other antiviral medications.
Eligibility:
\- Adults age 18 and older who have chronic hepatitis B and had therapy with 1 or more oral medicines for hepatitis B for at least 4 years.
Design:
* Participants will be screened with physical exam and medical history. They will complete health questionnaires about their levels of fatigue and pain. They will have blood and urine tests. They may have an eye exam.
* Participants also will have a Fibroscan. A test to measure how stiff your liver is.
* Eligible participants will have a liver biopsy. Blood will be drawn.
* Participants will be admitted to the NIH Clinical Center. They will be injected with the study drug. Then they will have a second liver biopsy. They will be discharged 24 hours later.
* Participants will give themselves study drug injections under the skin weekly for 24 weeks.
* Participants will have 5 clinic visits during the 24-week treatment period. Then they will have follow-up visits every 12 weeks for 48 weeks.
* During visits, participants may have a physical exam and medical history. They may have blood and urine tests. They may have a Fibroscan and complete questionnaires. At the final visit, they will also have a Fibroscan.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B
· Phase 1
· recruiting
NCT07135349 — A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B
· Phase 2
· active not recruiting
NCT07307586 — A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatiti
· Phase 3
· recruiting
NCT07246889 — Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)
· Phase 3
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last refreshed: 4 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02364336.