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Interferon

Peginterferon-alfa 2a and tenofovir for Hepatitis B (HBRN Trial)

Phase 3
Waitlist Available
Led By Anna Lok, MD
Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 240
Awards & highlights

HBRN Trial Summary

This trial compares the efficacy of two treatments for chronic hepatitis B. The primary measure of outcome will be HBsAg loss in serum at 48 weeks after stopping all antiviral therapy.

Eligible Conditions
  • Hepatitis B

HBRN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 240
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 240 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240
Secondary outcome measures
Absence of Detectable Antiviral Drug-Resistant HBV Mutations at Week 192
Hepatitis B Surface Antigens
Cumulative Percent of Participants With HBsAg Loss at Week 240
+15 more

Side effects data

From 2021 Phase 3 trial • 201 Patients • NCT01369212
7%
RASH
6%
DEPRESSION
5%
WEIGHT LOSS
3%
URINARY TRACT INFECTION
3%
ANEMIA
3%
THROMBOCYTOPENIA
3%
ELEVATED ALT
3%
PRURITUS
2%
PLATELET COUNT DECREASED
2%
FLU-LIKE SYMPTOMS
2%
HAIR LOSS
2%
INSOMNIA
2%
PREGNANCY
2%
HYPOPHOSPHATEMIA
2%
NEUTROPENIA
2%
WHITE BLOOD CELL DECREASED
2%
TOOTH EXTRACTION
2%
HEADACHE
2%
IRRITABILITY
2%
UPPER RESPIRATORY INFECTION
2%
ITCHING
2%
RASH AT INJECTION SITE
1%
PERIORBITAL EDEMA
1%
MUCUS IN THROAT
1%
DECREASED APPETITE
1%
DRY EYES
1%
EAR PAIN
1%
INTERMITTENT CONFUSION
1%
URTICARIA
1%
SUICIDAL THOUGHT
1%
FATIGUE
1%
GASTROCNEMIUS MUSCLE TEAR
1%
INCREASED JOINT AND MUSCLE PAIN
1%
URETERIC STONE RECURRENCE
1%
GASTRITIS
1%
HYPERTHYROIDISM
1%
HERPESVIRAL GINGIVOSTOMATITIS AND PHARYNGOTONSILLITIS
1%
HYPERTRIGLYCERIDEMIA
1%
RAPID HEART RATE
1%
NUMBNESS
1%
ERECTILE DYSFUNCTION
1%
HEARING LOSS
1%
RECONSTRUCTION OF BREAST
1%
FEVER
1%
SYMPTOMS OF FEELING SAD, IRRITABLE, TROUBLE SLEEP
1%
KIDNEY STONE
1%
TUBAL REVERSAL
1%
BRONCHITIS
1%
DYSURIA, URINARY FREQUENCY
1%
POOR LIBIDO AND RECURRENT UTI
1%
POST TUBAL REVERSION PROCEDURE WOUND INFECTION
1%
MENSES CEASED
1%
RASH, SKIN IRRITATION, ERYTHEMA AT INJECTION SITE
1%
LOW PLATELETS
1%
GAS AND DIARRHEA
1%
IRRITABLE BOWEL SYNDROME WITH DIARRHEA
1%
DERMATITIS HERPETIFORMIS
1%
ATRIAL FIBRILLATION
1%
COUGH
1%
ROSACEA
1%
BACK SPRAIN
1%
DRY COUGH ASSOCIATED WITH EATING/REFLUX
1%
BENIGN PAROXYSMAL POSITIONAL VERTIGO
1%
BREAST CANCER
1%
LOW ANC
1%
LYMPHOCYTE COUNT DECREASED
1%
MICROCYTIC ANEMIA
1%
WHITE BLOOD CELL, PLATELET COUNT, AND NEUTROPHIL
1%
CHEST DISCOMFORT
1%
CHEST PAIN
1%
CHEST PRESSURE
1%
HIGH CHOLESTEROL
1%
LOW TSH EPISODE
1%
ABDOMINAL PAIN, NAUSEA, GASTRIC REFLUX
1%
ACTIVE DUODENITIS WITH ULCER
1%
ACUTE APPENDICITIS
1%
CAMPYLOBACTER INFECTION
1%
DAILY NAUSEA AND DIZZINESS
1%
HELICOBACTER PYLORI
1%
NAUSEA
1%
UPPER ABDOMINAL PAIN
1%
UPSET STOMACH
1%
APHTHOUS ORAL ULCERS
1%
CHILLS
1%
EAR INFECTION/FUNGUS
1%
MALAISE
1%
NASAL CONGESTION AND POST NASAL DRIP
1%
OTITIS EXTERNA
1%
SINUSITIS
1%
TOOTHACHE
1%
ALT AND AST INCREASED
1%
SPASM LIKE PAIN IN RUQ
1%
RED ITCHY BUMPS/LESIONS ACROSS BODY
1%
SHINGLES
1%
ACHES AND PAINS
1%
BACK PAIN
1%
JOINT ACHES
1%
KNEE PAIN, LOWER BACK PAIN
1%
MUSCLE PAIN
1%
PROXIMAL HUMERUS FRACTURE
1%
DECREASED LIBIDO
1%
HALLUCINATIONS
1%
MOOD DISORDER
1%
MOOD SWING
1%
POLYNEUROPATHY
1%
LUNG INFECTION
1%
NON-PRODUCTIVE COUGH AND SHORTNESS OF BREATH
1%
REACTIVE AIRWAY DISEASE
1%
DRY SKIN AND HYPOPIGMENTATION
1%
POISON IVY RASH
1%
PSORIASIS
1%
REDNESS AND ITCHINESS AT INJECTION SITE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Peginterferon-alfa 2a and Tenofovir
Tenofovir

HBRN Trial Design

2Treatment groups
Experimental Treatment
Group I: TenofovirExperimental Treatment1 Intervention
Tenofovir 192 weeks
Group II: Peginterferon-alfa 2a and tenofovirExperimental Treatment1 Intervention
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir disoproxil
FDA approved
Hepatitis B Vaccine (Recombinant)
FDA approved

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,359 Previous Clinical Trials
4,315,294 Total Patients Enrolled
22 Trials studying Hepatitis B
13,685 Patients Enrolled for Hepatitis B
National Center for Research Resources (NCRR)NIH
537 Previous Clinical Trials
316,815 Total Patients Enrolled
2 Trials studying Hepatitis B
2,079 Patients Enrolled for Hepatitis B
University of PittsburghOTHER
1,722 Previous Clinical Trials
16,342,735 Total Patients Enrolled
3 Trials studying Hepatitis B
2,541 Patients Enrolled for Hepatitis B

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more spots available for this clinical trial?

"Unfortunately, this particular clinical trial is not looking for any more patients at the moment. This is according to the most recent update on clinicaltrials.gov, which was on September 14th, 2022. Although this is the case, there are 399 other trials that are currently recruiting patients."

Answered by AI

Are there many examples of research involving Peginterferon-alfa 2a and tenofovir?

"As of right now, there are 109 active clinical trials studying the efficacy of Peginterferon-alfa 2a and tenofovir. 35 of those trials are in the critical Phase 3. Most of the studies take place in Boylston, Massachusetts, but there are 1929 locations running studies for this treatment worldwide."

Answered by AI

Are there any limits to the amount of people who can join this trial?

"Unfortunately, this particular clinical trial is no longer recruiting patients. Although, if you are interested in other studies, there are 290 trials for hepatitis b and 109 trials for Peginterferon-alfa 2a and tenofovir that are currently looking for participants."

Answered by AI

Is this research being conducted at more than one facility in the United States?

"There are a total of 21 sites conducting this study. Some examples of cities with these sites are Dallas, Seattle and Honolulu. To limit travel as a time commitment, patients should try and enroll at the site closest to their location."

Answered by AI

What are the traditional applications for Peginterferon-alfa 2a and tenofovir?

"Peginterferon-alfa 2a and tenofovir can improve outcomes for patients with high-risk health conditions, liver disease, and those who engage in compensated sex work."

Answered by AI

Has the FDA cleared Peginterferon-alfa 2a and tenofovir for use?

"There is both efficacy and safety data available from Phase 3 trials, so our team has rated the Peginterferon-alfa 2a and tenofovir combination as a 3."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B
2012. "Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01369212.
~16 spots leftby Apr 2025
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