Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection

Chronic Hepatitis C Virus Infection Clinical Trial

Official title:

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-Naïve Subjects With Chronic HCV Genotype 2 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382937
• Other study ID #: A14-301
• Status: Completed
• Phase: Phase 3
• Start date: January 12, 2016
• Est. completion date: July 15, 2020

Study information

• Verified date: January 2022
• Source: PharmaEssentia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary objective:

To demonstrate non-inferiority in sustained virologic response (SVR, undetectable HCV RNA at Follow up week 12) between PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily for the treatment of chronic HCV genotype 2 infection

Description:

Secondary objective:

To determine and compare the efficacy, safety, tolerability and immunogenicity of PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: July 15, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Adults =18 years of age (or other age required by local regulations); subjects who are over 70 years of age must be in generally good health.

2. Confirmed diagnosis of chronic hepatitis with HCV genotype 2 infection. Chronicity is defined as having proven clinical evidence of chronic hepatitis, e.g. a duration of disease longer than 24 weeks before dosing, OR positive for anti-HCV antibody and HCV RNA at screening with biopsy-proven chronic hepatitis C, OR fibrosis.

3. Compensated liver disease defined by normal or elevated ALT =10 x ULN, total bilirubin level <2 mg/dL (except in Gilbert's syndrome), normal albumin, normal INR (INR =1.5)

4. Interferon treatment naïve: never received any interferon.

5. No other known form of chronic liver disease apart from chronic hepatitis C infection. But mild and moderate fatty liver diseases can be included.

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:

Any of the following is cause for exclusion from the study:

1. Decompensated liver disease, including overt clinical symptom and sign of complications related to portal hypertension.

2. Clinically significant illness or surgery within 4 weeks prior to dosing.

3. Any reason which, in the opinion of the investigator, would prevent the subject from participating in the study.

4. Positive test for hepatitis B surface antigen or human immunodeficiency virus at screening.

5. Clinically significant abnormal vital signs at screening.

6. Evidence of severe retinopathy by fundoscopy except age-related macular degeneration at screening.

7. Significant alcohol or illicit drug abuse within one year prior to the screening visit or refusal to abstain from excessive alcohol consumption as defined above or illicit drugs throughout the study.

8. Pregnant or breast feeding female subjects.

9. 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.

10. Use of an investigational drug or participation in an investigational drug trial within 4 weeks from the first dose.

11. Known clinically significant presence of any gastrointestinal pathology, clinically significant unresolved gastrointestinal symptoms, 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.

12. Hospital Anxiety and Depression Scale (HADS) score >10 on depression scale at screening that indicates clinically significant presence of depression determined by investigators.

13. Clinically significant presence of severe neurological disorders, e.g. uncontrolled seizure disorders.

14. Clinically significant presence of severe cardiovascular conditions and severe pulmonary conditions (including but not limited to pulmonary infiltrates, pneumonia, pneumonitis, chronic obstructive lung disease), uncontrolled immunologic, uncontrolled autoimmune, uncontrolled endocrine, uncontrolled metabolic, haematological, severe coagulation disorders or severe blood dyscrasias or other severe uncontrolled systemic disease.

15. A depot injection or an implant of any drug within 3 months prior to administration of study medication, other than contraception or hyaluronic acid injections in joints for osteoarthritis;

16. Body organ transplant and are taking immunosuppressants;

17. 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.

18. History of or ongoing opportunistic infection.

19. Serious local infection or systemic infection within the 3 months prior to screening.

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus Infection
• Communicable Diseases
• Hepatitis C
• Hepatitis C, Chronic
• Infections

Intervention

Drug:
• P1101 + Ribavirin
P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily
• PEG-Intron + Ribavirin
PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily

Locations

Country	Name	City	State
China	Beijing Ditan Hospital Capital Medical University	Beijing
China	Gansu Wuwei Tumour Hospital	Gansu
China	The First Hospital of Lanzhou University	Gansu
China	The Fourth Affiliated Hospital of Harbin Medical University	Harbin
China	Henan Provincial People's Hospital	Henan
China	Luoyang Central Hospital	Henan
China	The First Hospital of Jilin University	Jilin
China	Peace Hospital Affiliated to Changzhi Medical College	Shanxi
China	The Sixth People's Hospital of Shenyang	Shenyang
China	Tangdu Hospital, Fourth Military Medical University	Xi'an
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an
China	Xijing Hospital, Fourth Military Medical University	Xi'an
Korea, Republic of	Soonchunhyang University Seoul Hospital	Asan
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Inha University Medical Center	Incheon
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Seoul Metropolitan Government - Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Yonsei University Gangnam Severance Hospital	Seoul
Korea, Republic of	Saint Vincent Catholic Hospital	Suwon
Taiwan	Changhua Christian Hospital	Changhua City
Taiwan	Chang Gung Memorial Hospital, Chiayi Branch	Chiayi City
Taiwan	Chia-Yi Christian Hospital	Chiayi City
Taiwan	Dalin Tzu Chi Hospital	Chiayi City
Taiwan	St. Martin De Porres Hospital	Chiayi City
Taiwan	Hualien Tzu Chi Hospital	Hualien City
Taiwan	Chang Gung Memorial Hospital, Kaohsiung Branch	Kaohsiung City
Taiwan	E-Da Hospital	Kaohsiung City
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City
Taiwan	Chang Gung Memorial Hospital, Keelung Branch	Keelung
Taiwan	Chang Gung Memorial Hospital, Linkou	New Taipei City
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung City
Taiwan	Chi Mei Hospital, Liouying	Tainan City
Taiwan	Chi Mei Medical Center	Tainan City
Taiwan	National Cheng Kung University Hospital	Tainan City
Taiwan	National Taiwan University Hospital	Taipei City
Taiwan	Taitung MacKay Memorial Hospital	Taitung
Taiwan	National Taiwan University Hospital Yun-Lin Branch	Yuanlin

Sponsors (1)

Lead Sponsor	Collaborator
PharmaEssentia

Countries where clinical trial is conducted

China,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects with undetectable serum HCV RNA at follow up week 12	Percentage of subjects with SVR12 (undetectable serum HCV RNA, i.e. <12 IU/mL, at follow up week 12) in each treatment group	Follow Week 12
Secondary	Subjects with undetectable serum HCV RNA	Percentage of subjects with undetectable serum HCV RNA at treatment week 4, 8, 12, 24 (end of treatment) and follow up week 24 in each treatment group	Treatment Week 4, 8, 12, 24 and Follow Week 24
Secondary	Number of subjects with adverse events	Number of subjects with adverse events in each treatment group	Through study Follow Week 24
Secondary	Number of subjects with clinically significant laboratory abnormalities	Number of subjects with clinically significant laboratory abnormalities in each treatment group	Through study Follow Week 24
Secondary	Subjects with anti-drug antibodies	Percentage of subjects with positive anti-drug antibodies (the anti-peginterferon and the anti-Peg) at follow up week 12 and 24	Follow Week 12 and 24
Secondary	Subjects with neutralizing antibody	Percentage of subjects with positive neutralizing antibody at follow up week 12 and 24	Follow Week 12 and 24