Clinical Trials List
2012-06-01 - 2014-08-31
Phase I/II
Terminated9
ICD-10B16.9
Acute hepatitis B without delta-agent and without hepatic coma
ICD-10B19.10
Unspecified viral hepatitis B without hepatic coma
ICD-9070.30
Viral hepatitis B without mention of hepatic coma, acute or unspecified, without mention of hepatitis delta
A Phase I/II, Open-label, Randomized, Active Control, Dose Finding Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of P1101 in Interferon-Naïve Subjects with Chronic Hepatitis B Virus Infection
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Trial Applicant
Clinipace Taiwan Co., Ltd
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Sponsor
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Trial scale
Taiwan Multiple Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 張家昌 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Yi-Cheng Chen Digestive System Department
- Rong-Nan Chien Digestive System Department
- Chen-Chun Lin Digestive System Department
- Chau-Ting Yeh Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Chun-Jen Liu Digestive System Department
- Chen-Hua Liu Digestive System Department
- Jia-Horng Kao Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Chen-Hua Liu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Ming-Lun Yeh Digestive System Department
- Ming-Lung Yu Digestive System Department
- Chia-Yen Dai Digestive System Department
- Jee-Fu Huang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Chien-Wei Su Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 蘇文邦 Digestive System Department
- 高榮達 Digestive System Department
- Hsueh-Chou Lai Digestive System Department
- 賴學州 Digestive System Department
- 陳昇弘 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
treatment and follow up across treatment groups;
• Percentage of subjects with biochemical response (normalization of ALT) at the end of
treatment and follow up across treatment groups;
• Percentage of subjects with reduction of serum HBsAg levels to <1,000 IU/mL at the end
of treatment and follow up across treatment groups;
• Adverse event, vital sign, ECG and laboratory results across treatment groups;
• Pharmacokinetic parameters of P1101, including Cmax, Tmax, Cmin, Ct, λz, T ½, AUC0-t,
AUC0-∞, AUC0-tau, and Cavg-ss across treatment groups;
Inclution Criteria
Subjects eligible for enrolment in the study must meet all of the following criteria:
1. Adults ≥ 20 years of age; subjects who are over 70 years of age must be in generally good
health.
2. Confirmed diagnosis of chronic hepatitis B (CHB) virus infection: (1) Positive for HBsAg
for at least 6 months before screening or documented negative IgM anti-HBc within 6
months before screening; and (2) documented elevated ALT, i.e. 2-5 X ULN at least within
3 months before screening and at screening visit; (3) serum HBV DNA >20,000 IU/mL for
both HBeAg(+) and HBeAg(-);
3. Compensated liver disease, which includes but not limited to the followings: albumin level
(≥ 3.5 g/dL), PT within the normal range of the laboratory, INR ≦ 1.5; no history nor
clinical evidence of ascites, cirrhosis, liver decompensation, hepatic encephalopathy,
esophageal varices or portal hypertension as identified by ultrasound or any other
procedures before study entry;
4. Interferon treatment naïve: never received interferon before;
5. No other form of chronic liver disease apart from chronic hepatitis B infection;
6. Negative for human immunodeficiency virus, hepatitis C and hepatitis D infection;
7. Normal fundoscopic examination at screening, defined as no significant or major
fundoscopic findings including but not limited to retinal exudates, hemorrhage, detachment,
neovascularization, papilloedema, optic atrophy, microaneurysms and macular changes.
8. Be able to attend all scheduled visits and to comply with all study procedures;
Exclusion Criteria
Subjects who meet any of the following criteria at the baseline visit (Visit 1) must be excluded
from this study:
1. Clinically significant illness or surgery within 4 weeks prior to dosing;
2. Clinically significant vital sign abnormalities, uncontrolled hypertension, or fever [body
temperature >38℃]) at screening;
3. BMI > 28
4. Clinically significant abnormal laboratory test result at screening which includes but not
limited to the followings: WBC < 3,000/mm3
, ANC < 1500/mm3
, Hgb < 10g/dL, platelet
<100,000/mm3 or other abnormal values that should be excluded at the investigator’s
discretion.
5. History of significant alcohol or drug abuse within six months prior to the screening visit
(alcohol consumption of more than fourteen units of alcohol per week [1 Unit = 150 mL of
wine, 360 mL of beer, or 45 mL of 40% alcohol]) or refusal to abstain from alcohol or illicit
drugs throughout the study;
6. Pregnant subjects, female subjects or the spouse of male subjects, with child-bearing
potential who are unwilling or unable to practice adequate contraception, defined as
vasectomy in men, tubal ligation in women, or use of condoms and spermicides, or birth
control pills, or intrauterine devices throughout the study;
7. History of severe allergic or hypersensitivity reactions (like angioedema), specifically
asthma, any known reaction to the study medication, allergic skin rash or other allergic
reactions (like anaphylaxis), including severe drug allergies;
8. Therapy with any systemic anti-viral treatment, anti-neoplastic, and immunomodulatory
treatment (including supraphysiologic doses of steroids and radiation) within 1 month (3
months for those with long elimination half-live) prior to the first dose of study drug;
9. Use of an investigational drug within the last 4 weeks;
10. Clinically significant history or presence of any kidney disease (including but not limited to those with chronic renal failure on dialysis), or other conditions known to interfere with the
absorption, distribution, metabolism, or excretion of the drug;
11. Any clinically significant history or presence of poorly controlled major psychiatric
(including but not limited to those with severe depression, severe bipolar disorder,
schizophrenia, suicidal ideation or history of suicidal attempt), neurological, cardiovascular
(e.g. uncontrolled hypertension), pulmonary (including but not limited to chronic obstructive
lung disease), hematological, immunologic, endocrine, metabolic or other uncontrolled
systemic disease, coagulation disorders or blood dyscrasias;
12. A depot injection or an implant of any drug within 3 months prior to administration of study
medication, other than contraception;
13. Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of
whole blood (excluding the volume of blood that will be drawn during the screening
procedures of this study) prior to administration of the study medication as follows: 50 mL
to 499 mL of whole blood within 30 days, or more than 499 mL of whole blood within 56
days prior to drug administration.
14. Body organ transplant and are taking immunosuppressants;
15. History of malignant disease, including solid tumors and hematologic malignancies (except
basal cell and squamous cell carcinomas of the skin that have been completely excised and
are considered cured). Cancer survivors not on maintenance therapy that had no malignant
diseases history within the past 5 years could be recruited.
16. History of opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
17. Serious localized infection (e.g., cellulitis, abscess) or systemic and
life-threatening infection (e.g., septicemia) within the 3 months prior to screening.
18. Inability to comprehend the written consent form;
The Estimated Number of Participants
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Taiwan
80 participants
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Global
80 participants
