Phase 2
N=13
Add-on Peginterferon Following Nucleos(t)Ide Analogue Treatment
Chronic Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT02364336 ↗Enrolled (actual)
13
Serious AEs
7.7%
Results posted
Aug 2019
Primary outcome: Primary: Change in Interferon-stimulated-gene (ISG) Expression — -2.716; 1.670; -2.20; -1.597 log 2 fold change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Peginterferon alfa-2a (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Interferon-stimulated-gene (ISG) Expression |
-2.716; 1.670; -2.20; -1.597; -1.184; -1.382 | — |
| SECONDARY Hepatitis B e Antigen (HBeAg) Loss |
0; 0; 0 | — |
| SECONDARY Hepatitis B s Antigen (HBsAg) Loss |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Change in Natural Killer (NK) Cell Frequency |
15.60; 11.82; 10.30; 13.74; -5.3; 1.92 | — |
| SECONDARY Change in Natural Killer (NK) Cell Degranulation |
0.08; 0.64; 0.06; 0.52; -0.02; -0.12 | — |
Summary
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.
Eligibility Criteria
- INCLUSION CRITERIA:
Inclusion criteria: HBeAg positive group
- Age >18 years and older, male or female.
- Known serum HBsAg and HBeAg positivity at the time of screening.
- Ongoing treatment with one or more NUCs for at least 192 weeks before study entry. Subjects may have a brief interruption of treatment for medical reasons (e.g. breast feeding) not to exceed 8 weeks and none within the 48 weeks before study entry.
- HBV DNA levels 18 years and older, male or female.
- Known serum HBsAg positivity and HBeAg negativity at the time of screening.
- Ongoing treatment with one or more NUCs for at least 192 weeks before study entry. Subjects may have a brief interruption of treatment for medical reasons (e.g. breast feeding) not to exceed 8 weeks and none within the 48 weeks before study entry.
- HBV DNA levels 2.5 mg/dL (with direct bilirubin > 0.5 mg/dL), prothrombin time of greater than 2 seconds prolonged, a serum albumin of less than 3 g/dL, or a history of ascites, variceal bleeding or hepatic encephalopathy.
- Presence of other causes of liver disease, (i.e. hemochromatosis, Wilson disease, alcoholic liver disease, severe nonalcoholic steatohepatitis defined as the presence of marked ballooning injury on liver biopsy, alpha-1-anti-trypsin deficiency).
- A history of organ transplantation or in the absence of organ transplantation, any immunosuppressive therapy requiring the use of more than 5 mg of prednisone (or its equivalent) daily.
- Significant systemic illness other than liver diseases including congestive heart failure, renal failure, chronic pancreatitis and diabetes mellitus with poor control, that in the opinion of the investigator may interfere with therapy.
- Pregnancy or inability to practice contraception in patients capable of bearing or fathering children
- Lactating women.
- Hepatocellular carcinoma (HCC), or the presence of a mass on imaging studies of the liver that is suggestive of HCC, or an alpha-fetoprotein level of greater than 500 ng/mL.
- eGFR 1.3 mg/dl or urine protein >1 gram/24-hours
- History of hypersensitivity to pegylated interferon-alpha
- Platelet count 1, 000 IU/ml while off therapy.
Data sourced from ClinicalTrials.gov (NCT02364336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.