Clinical Trials List
2017-02-17 - 2020-12-17
Phase III
Recruiting8
Terminated3
ICD-10K50.90
Crohn's disease, unspecified, without complications
ICD-10K50
Crohn's disease [regional enteritis]
ICD-9555.9
Regional enteritis, unspecified site
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects with Crohn’s Disease
-
Trial Applicant
Pharmaceutical Research Associates Taiwan Inc.
-
Sponsor
Gilead Sciences Hong Kong Limited Taiwan Branch
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 康瑞文 Division of General Internal Medicine
- Po-Wen Lin Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- 張安迪 無
- Chun-Lung Feng Division of General Internal Medicine
- Tsung-Yu Tsai 未分科
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王賀立 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 姜正愷 Division of General Internal Medicine
- 楊純豪 Division of General Internal Medicine
- Chun-Chi Lin Division of General Internal Medicine
- 張世慶 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chun-Lung Feng 未分科
Audit
None
Chairman/Global PI
Co-Principal Investigator
Audit
CRO
Co-Principal Investigator
- YEN-HSUAN NI Digestive System Department
- 謝銘鈞 Digestive System Department
- 翁昭旼 Digestive System Department
- SHU-CHEN WEI Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- Yu-Chung Su Division of General Internal Medicine
- Huang-Ming Hu Division of General Internal Medicine
- Fang-Jung Yu Yu Division of General Internal Medicine
- HSIANG YAO SHIH Division of General Internal Medicine
- Chien-Yu Lu Division of General Internal Medicine
- Wen-Hung Hsu Division of General Internal Medicine
- Chao-Hung Kuo Division of General Internal Medicine
- I-CHEN WU Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Taiwan National PI
Co-Principal Investigator
- 林蔚然 Division of General Internal Medicine
- Cheng-Yu Lin Division of General Internal Medicine
- Puo-Hsien Le 無
- 陳聰興 Division of General Internal Medicine
- Puo-Hsien Le 未分科
- Chia-Jung Kuo Division of General Internal Medicine
- Wen-Sy Tsai Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
1 Recruiting
Audit
None
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
throughout the duration of the study. Safety evaluations include
documentation of AEs, PE (symptom driven), vital signs, and
clinical laboratory evaluations (hematology, chemistry, and
urinalysis). An ECG will be performed every 48 weeks.
Efficacy: Efficacy will be evaluated in terms of changes in PRO2 and CDAI scores.
Biomarkers: Blood samples will be collected at Day 1 and then every 24 weeks
thereafter for the assessment of markers of inflammation and immune status.
Inclution Criteria
Subjects will be eligible if they meet all of the following inclusion
criteria:
1) Must have the ability to understand and sign a written informed
consent form (ICF), which must be obtained prior to initiation
of study procedures associated with this trial
2) Must have met all eligibility criteria from a Gilead-sponsored
CD parent protocol
3) Females of childbearing potential must have a negative
pregnancy test at Day 1 and must agree to continued monthly
pregnancy testing during use of filgotinib treatment
4) Male subjects and female subjects of childbearing potential who
engage in heterosexual intercourse must agree to use protocol
specified method(s) of contraception as described in
Appendix 6, for the duration described
5) Willingness to refrain from live or attenuated vaccines during
the study and for 12 weeks after last dose of study drug
6) Must have completed all required procedures or met protocol
specified efficacy discontinuation criteria in a prior
Gilead-sponsored filgotinib treatment study for CD
Exclusion Criteria
Subjects who meet any of the following exclusion criteria are not to be enrolled in the study.
1) Subjects who are discontinued from a parent study for reasons
other than disease worsening or lack of response or remission;
eg, subjects who discontinue for safety or tolerability issues are not eligible for this study
2) Known hypersensitivity to the study drug
3) Any chronic medical condition (including, but not limited to,
cardiac or pulmonary disease, alcohol or drug abuse) that, in the
opinion of the Investigator or Sponsor, would make the subject
unsuitable for the study or would prevent compliance with the study protocol
4) Females who may wish to become pregnant and/or plan to
undergo egg donation or egg harvesting for the purpose of
current or future fertilization during the course of the study and
for at least 35 days of the last dose of the study drug
5) Male subjects unwilling to refrain from sperm donation for at
least 90 days after the last dose of study drug
6) Males or females of reproductive potential who are unwilling to
abide by protocol-specified contraceptive methods as defined in Appendix 6
7) Use of prohibited concomitant medications as outlined in Section 5.4.2
The Estimated Number of Participants
-
Taiwan
26 participants
-
Global
1000 participants
