A MULTICENTER OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PEG-INTRON™ VERSUS PEGASYS™ IN SUBJECTS WITH HBEAG POSITIVE CHRONIC HEPATITIS B AND HBEAG NEGATIVE CHRONIC HEPATITIS B

Not Applicable

• Conditions: -B18 Chronic viral hepatitis; Chronic viral hepatitis; B18

• Registration Number: PER-025-13
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Each subject must provide written informed consent for the trial.
2. To participate in the pharmacogenetic analysis, the subject must give written informed consent for the pharmacogenetic testing and able to adhere to dose and visit schedules. Note: A subject unwilling to sign the informed consent for pharmacogenetic testing may be included in the trial; however, pharmacogenetic samples must not be obtained
3. Each subject must be able to adhere to dose and visit schedules.
4. Subject must be 18 years of age.
5. Subject must weigh  40 kg.
6. Subject must be HBsAg (+) for at least 6 months prior to screening.
7. Subject must be anti-HBs negative.
8. Subject must have HBV DNA > 20,000 IU/mL.
9. Serum ALT levels >1x ULN.
10. Female subjects of childbearing potential must agree to use an acceptable method of effective contraception from at least 2 weeks prior to Day 1 and continue until at least 1 month after last dose of study drug.
Acceptable methods of effective contraception for females are:
a) Hormonal or non-hormonal intrauterine device (IUD)
b) Appropriate contraception registered for marketing containing an estrogen and/or progesterone agent (oral, transdermal, intramuscular, vaginal ring, or implant)
c) Diaphragm and spermicide
d) Sponge and spermicide
e) Cervical cap and spermicide

For the purposes of this protocol, a woman of non-childbearing potential is defined as one who has either 1) reached natural menopause (defined as at least 12 consecutive months of spontaneous amenorrhea), 2) 6 weeks post surgical bilateral oopherectomy with or without hysterectomy, or 3) bilateral tubal ligation.
HBeAg (+) subjects:
1. Subject must be HBeAg (+)
2. Subject must be anti-HBe (-)
HBeAg (-) subjects:
1. Subject must be HBeAg (-)
2. Subject must be anti-HBe (+)

Exclusion Criteria

1.Co-infections with the human immunodeficiency virus (HIV) or hepatitis C or hepatitis D virus.
2.Prior treatment with interferon for hepatitis B.
3.Use of nucleos(t)ide analogues within 6 months of the screening visit or at any time during the study.
4.Use of any investigational drug within 30 days of the screening visit.
•Prior treatment with herbal remedies with known hepatotoxicity is exclusionary. All herbal remedies used for hepatitis B treatment must be discontinued before Day 1. Only silibinin-based products such as silymarin (milk thistle) are allowed during the trial.
5.Participation in any other clinical trial, except observational trials, within 30 days of the screening visit in this trial or intention to participate in another clinical trial.
6.Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
7.Diabetic and/or hypertensive subjects with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality.
8.Pre-existing psychiatric condition(s), including but not limited to:
a.Current moderate or severe depression.
b.History of depression associated with any of the following:
i.Hospitalization for depression.
ii.Electroconvulsive therapy for depression.
iii.Depression that resulted in a prolonged absence from work and/or significant disruption of daily functions.
c.Suicidal or homicidal ideation and/or attempt.
d.History of severe psychiatric disorders (including but not limited to schizophrenia, psychosis, bipolar disorder, post-traumatic stress disorder or mania).
e.Past history or current use of lithium.
f.Past history or current use of antipsychotic drugs for those conditions listed in Exclusion Criterion No. 8d.
9.History of stroke or transient ischemic attack
10.Immunologically mediated disease (e.g., inflammatory bowel disease [Crohn’s disease, ulcerative colitis], celiac disease, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, sarcoidosis, severe psoriasis requiring oral or injected treatment, or symptomatic thyroid disorder).
11.Chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis).
12.Current or history of any clinically significant cardiac abnormalities/dysfunction (e.g., angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia) including current uncontrolled hypertension or history of use of antianginal agents for cardiac conditions.
13.Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial.
14.Myelodysplastic syndromes.
15.Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
16.Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible.
17.Subjects who are pregnant or nursing. Subjects who intend to become pregn

Study & Design

• Study Type: Interventional
• Study Design: Not specified