Clinical Trials List
2015-04-01 - 2020-12-31
Phase III
Terminated20
An Open-label, Randomized, Active Control Study to Demonstrate Non-Inferiority in Efficacy, and to Compare Safety and Tolerability of P1101 + Ribavirin to PEG-Intron + Ribavirin in Interferon Treatment-Naive Subjects with Chronic HCV Genotype 2 Infection
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Trial Applicant
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Sponsor
PharmaEssentia
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 陳建宏 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Chao-Wei Hsu Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Rong-Nan Chien Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Cheng-Yuan Peng Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Pin-Nan Cheng Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 陳志州 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 陳啟益 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 蘇維文 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Sheng-Shun Yang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 曾國枝 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 羅清池 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 洪肇宏 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 郭行道 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 胡志棠 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 白明忠 Digestive System Department
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
- Shih-Jer Hsu 未分科
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Co-Principal Investigator
- Chien-Wei Su Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
A. Primary endpoint(s):
Percentage of subjects with SVR12 (undetectable serum HCV RNA,
i.e. <12 IU/mL, at follow up week (FW) 12) in each treatment group
B. Secondary endpoints:
Percentage of subjects with undetectable serum HCV RNA at treatment week (TW) 4, 8, 12, 24 (end of treatment) and FW24 in each treatment group.
Adverse events and clinically significant laboratory abnormalities in each treatment group
Percentage of subjects with positive anti-drug antibodies (the anti-peginterferon or the anti-Peg) or neutralizing antibody at FW12 and 24
2. Safety: Adverse events and clinically significant laboratory abnormalities in each treatment group.
3. Pharmacokinetics: Percentage of subjects with positive anti-drug antibodies (ADAs) or neutralizing antibody at FW12 and 24
Inclution Criteria
(2) Confirmed diagnosis of chronic hepatitis C virus genotype 2 infection, i.e. a duration of disease longer than 6 months before screening, OR positive for anti-HCV antibody and HCV RNA at screening with biopsy-proven chronic hepatitis C, AND positive for HCV genotype 2.
(3) Compensated liver disease defined by normal or elevated ALT/AST ≤10x ULN, total bilirubin level <2 mg/dL (except in Gilbert’s syndrome), normal albumin, normal PT/INR (INR ≤1.5)
(4) Treatment naïve: never received any interferon, ribavirin or any direct anti-viral treatment for HCV;
(5) No other form of chronic liver disease apart from chronic hepatitis C infection;
(6) Hemoglobin≥12 g/dL in men or ≥11 g/dL in women, WBC count ≥3,000/mm3 , ANC≥1,500/mm3
, platelet count≥90,000/mm3 ; and estimated glomerular filtration rate >60 mL/min.
(7) Female and male subjects, and their partners of reproductive potential
using effective means of contraception during the whole trial period.
(8) Be able to attend all scheduled visits and to comply with all study procedures;
(9) Be able to provide written informed consent
Exclusion Criteria
(2) Overt clinical symptoms and signs of complications related to portal hypertension
(3) Clinically significant illness or surgery within 4 weeks prior to dosing
(4) Any clinically significant abnormality or clinically significant abnormal
laboratory test results found during medical screening except serum AST/ALT.
(5) Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.
(6) Positive test for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV) at screening.
(7) Clinically significant abnormal vital signs at screening.
(8) Evidence of severe retinopathy by fundoscopy or severe ophthalmological disorders at screening.
(9) History of significant alcohol or drug abuse within one year 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 excessive alcohol consumption as defined above or
illicit drugs throughout the study.
(10) Pregnant or breast feeding female subjects.
(11) Therapy with any systemic anti-viral, anti-neoplastic, and immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 4 weeks prior to the first dose of study drug.
(12) Use of an investigational drug or participation in an investigational drug trial within 4 weeks from the first dose.
(13) Clinically significant history or presence of any gastrointestinal pathology
(e.g., chronic diarrhea, inflammatory bowel diseases), clinically significant unresolved gastrointestinal symptoms (e.g., diarrhea, vomiting), clinically significant liver (other than CHC) or clinically significant 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.
(14) Any clinically significant history or presence of major psychiatric disorders
(including but not limited to severe depression, severe bipolar disorder, schizophrenia, suicidal ideation or history of suicidal attempt).
(15) Hospital Anxiety and Depression Scale (HADS) score >10 on either scale at screening.
(16) History of or ongoing severe neurological disorders, e.g. uncontrolled seizure disorders.
(17) History of or ongoing severe cardiovascular conditions (e.g. uncontrolled hypertension of over 150/90 mmHg) and severe pulmonary conditions (including but not limited to pulmonary infiltrates, pneumonia, pneumonitis,
chronic obstructive lung disease), uncontrolled immunologic, uncontrolled
autoimmune, uncontrolled endocrine (e.g. hypothyroidism, hyperthyroidism),
uncontrolled metabolic (e.g. diabetes mellitus with HbA1C >7.5%),
haematological, severe coagulation disorders or severe blood dyscrasias or other severe uncontrolled systemic disease.
(18) A depot injection or an implant of any drug within 3 months prior to administration of study medication, other than contraception;
(19) Body organ transplant and are taking immunosuppressants;
(20) 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, and carcinoma in
situ of cervix); However, subjects who are cancer survivors not on maintenance therapy and who had no malignant diseases history within the past 5 years could be recruited.
(21) History of or ongoing opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
(22) Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within the 3 months prior to screening.
The Estimated Number of Participants
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Taiwan
110 participants
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Global
222 participants
