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Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis

Primary Purpose

Moderate to Severe Ulcerative Colitis

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hemay005 tablets
Hemay005 placebo tablets
Sponsored by
Ganzhou Hemay Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Willing to participate in the trial and signing the informed consent forms;
  • Age ≥18 years old, male or female;
  • Diagnosed as ulcerative colitis (UC) ≥ 3 months at screening with clinical manifestations and evidence of endoscopy and confirmed by histopathological reports;
  • Expansion of the affected bowel segment beyond the rectum confirmed on endoscopy (affected bowel segment≥15cm);
  • Moderate to severe ulcerative colitis with Modified Mayo clinical score (MMCS)≥ 4 points and ≤9 points, the Endoscopy subscore ≥ 2 points within 14 days before randomization and Stool Frequency subscore ≥ 1 point;
  • UC treatment failure or intolerance (intolerance is defined as the discontinuation of drug use due to adverse reactions judged by the investigators) experienced by patients using at least one of the following:

Oral administration of sulfasalazine (SASP) and/or 5-aminosalicylic acid (5-ASA); Oral administration of corticosteroids; Azathioprine or 6-mercaptopurine; Anti-TNF-α treatment: infliximab or adalimumab, etc.; - If the patient is using the following drugs to treat ulcerative colitis at the time of screening, it is necessary to receive stable treatment during the screening period and the following requirements during the study period are as follows: Oral administration of sulfasalazine (SASP) and/or 5-aminosalicylic acid (5-ASA) maintaining stable for at least ≥ 2 weeks prior to endoscopy during the screening period and maintaining stable during the study period; and/or Oral administration of low-dose corticosteroids (≤25 mg/d prednisolone or equivalent drug dose) maintaining stable for at least ≥ 2 weeks prior to endoscopy during the screening period;

- At least one of the following effective contraceptive methods should be adopted for female patients with fertility and male patients who have not undergone vasectomy during the entire study period from the date of signing the informed consent to 3 months after the last dose. Acceptable contraceptive methods in this study include: a. abstinence; b. hormones (oral intake, patch, ring, injection, implantation) combined with male condoms. This measure must be applied at least 30 days prior to the first administration of investigational drug, otherwise another acceptable method of contraception must be used; c. intra-uterine device (IUD) combined with male condoms; d. barrier method (diaphragm, cervical cap, sponge) combined with male condoms; exceptional circumstances: a) females who have been menopausal for 5 years and more, and b) surgical sterilization (proof should be provided).

Exclusion Criteria:

  • Pregnant or lactating women, or women or men whose partners planning to become pregnant during the study;
  • Knownto be allergic to any component of Hemay005 tablets (the main component is hemay005, and the main excipients are mannitol, low substituted hydroxypropyl cellulose, croscarmellose sodium and magnesium stearate);
  • Patients with suspected or confirmed Crohn's disease, undiagnosed types of colitis, fulminant colitis, toxic megacolon, microscopic colitis, ischemic colitis or radioactive colitis based on medical history and endoscopy and/or histological results;
  • Patients with active EBV and/or CMV infection (EBV antibody IgM and/or EBV DNA positive); CMV antibody IgM and/or CMV DNA positive);
  • Patients with the disease confined to the rectum (ulcerative proctitis) according to the endoscopy during screening;
  • Patients who have undergone surgical treatment for ulcerative colitis or who require surgery during the study;
  • Patients with active infection or positive pathogen test at the time of screening, and determined by the investigator to increase the risk of the subject, except for those with negative repeat test results and no symptoms of persistent infection (if time permits, during screening treatment and repeat testing);
  • Patients receiving the following treatments:

Patients who have used azathioprine/6-mercaptopurine, methotrexate within 7 days before randomization; Patients who have used cyclosporine, mycophenolate mofetil, tacrolimus/sirolimus within 4 weeks before randomization; Patients who have used interferon within 8 weeks before randomization; Patients who have received anti-TNF-α treatment within 8 weeks before randomization; Intravenous corticosteroids or rectal administration of corticosteroids or rectal administration of 5-ASA within 2 weeks prior to randomization; Patients who have used thalidomide within 8 weeks before randomization;Patients who have received antibiotic treatment within 1 week before randomization;

  • Patients with active infection and judged by the investigator to increase the risk of the subjects;
  • Patients with a history of TB or active TB (Investigator-judged signs or symptoms of active tuberculosis at screening):

Screening was permitted if patients had a history of tuberculosis and had been cured by investigator assessment for at least 3 years prior to randomization; subjects with a negative T-cell test for tuberculosis infection (T-SPOT) at screening can be included in this study. Subjects who are T-SPOT positive during the screening period need to undergo tuberculosis-related clinical examinations (Tuberculosis-related clinical work performed within 12 weeks prior to randomization can be used directly for evaluation), if the tuberculosis-related clinical examination confirmed active tuberculosis, the subjects will not be eligible for this study. Subjects can be included in this study if the tuberculosis-related clinical examination confirms inactive tuberculosis. If the research center cannot perform T-SPOT test, TB screening by QuantiFERON-TB Gold test kit can also be accepted. The treatment of QuantiFERON-TB-Gold screening results is the same as that of T-SPOT.

  • Patients with hemoglobin <8 g/dL or hematocrit <30%, white blood cells <3.0 × 10^9/L or neutrophils <1.2 × 10^9/L, platelets <100 × 10^09/L at screening;
  • Total bilirubin (TBIL), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 upper limits of normal (ULN) at screening;
  • Glomerular filtration rate (eGFR) ≤ 40 ml/min;
  • Patients with hereditary immunodeficiency disease;
  • Patients with a history of lymphoproliferative disorders (e.g. EBV-related lymphoproliferative disorders), or with lymphoma, leukemia, myeloproliferative disease, multiple myeloma;
  • Lymphocyte apheresis or selective mononuclear granulocyte apheresis was performed within 12 months before the screening or is planned to be performed during the study;
  • Patients with malignant tumor or with a history of malignancy other than well-treated or resected basal cell or squamous cell skin cancer;
  • Patients with conditions that may affect oral drug absorption, e.g. gastrectomy or clinically significant diabetes-related gastrointestinal disorders, or specific types of obesity surgery such as gastric bypass, however, patients only subjected to the division of the stomach into independent chambers, like gastric banding, will not be excluded;
  • Patients with previous surgery on small intestine or colon and with evidence of colonic dysplasia or intestinal stenosis;
  • Patients with chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) and hepatitis B core antibody (HBcAb) should be assessed for all patients during screening: patients with positive hepatitis B surface antigen (HBsAg) will be excluded; patients with HBsAg (negative), HBsAb (negative or positive) and HBcAb (positive) should be tested for HBV-DNA, and if the HBV-DNA result is positive, patient will be excluded; if the HBV-DNA result is negative, patients can be enrolled in the study.), chronic hepatitis C virus (HCV) infection (patients with positive hepatitis C virus antibody (HCVAb) excluded) or human immunodeficiency virus (HIV) infection (patients with positive human immunodeficiency virus (HIV) antibody excluded) or Syphilis (TP) infection (excluded patients with Treponema pallidum antibody (Anti-TP) positive);
  • Patients receive any live vaccine at present or has received any live vaccine within 8 weeks prior to randomization, or have been vaccinated against COVID-19 within 14 days prior to randomization;
  • Use of cytochrome P450 enzyme inducers (such as rifampicin, phenobarbital, dexamethasone, isoniazid, carbamazepine, etc.) within 14 days before screening;
  • Suicidal behavior (including active attempts, interrupted attempts, or attempted attempts) or suicidal thoughts within the past 6 months;
  • Other conditions that the investigator judges as unsuitable to participate in the study.

Sites / Locations

  • The Fourth Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Fujian Medical UniversityRecruiting
  • The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • First Affiliated Hospital of Zhengzhou University
  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
  • Xiangya Hospital of Central South University
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • Shengjing Hospital Affiliated to China Medical UniversityRecruiting
  • Qilu Hospital of Shandong University
  • Shandong Provincial Hospital
  • Sichuan Provincial People's HospitalRecruiting
  • First Affiliated Hospital of Zhejiang University School of Medicine
  • Beijing Chaoyang Hospital Affiliated to Capital Medical University
  • Beijing Friendship Hospital Affiliated to Capital Medical UniversityRecruiting
  • Peking University Third HospitalRecruiting
  • Chongqing People's HospitalRecruiting
  • Shanghai Oriental Hospital
  • Tianjin Medical University General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Hemay005 45 mg BID group

Hemay005 60 mg BID group

Hemay005 placebo BID group

Arm Description

3 tablets of Hemay005 (15mg/tablet) and 1 tablet of Hemay005 placebo will be orally administered twice daily.

4 tablets of Hemay005 (15mg/tablet) will be orally administered twice daily.

4 tablets of Hemay005 placebo will be orally administered twice daily.

Outcomes

Primary Outcome Measures

clinical remission
Definition of clinical remission rate: defined as a Mayo score of 0 or 1 in the number of bowel movements with a ≥1 reduction from baseline, a blood in the stool score of 0, and an endoscopic score of 0 or 1 (no fragility).

Secondary Outcome Measures

clinical response
Definition of clinical response: defined as a Mayo score reduction of ≥2 points from baseline and a decrease of ≥30% from baseline, with a reduction of ≥1 point from baseline in the rectal bleeding sub-score, or a rectal bleeding sub-score of ≤1 point.

Full Information

First Posted
August 1, 2022
Last Updated
September 20, 2023
Sponsor
Ganzhou Hemay Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05486104
Brief Title
Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis
Official Title
A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Low-High Dosing Regimens of Hemay005 in Patients With Moderate to Severe Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ganzhou Hemay Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a multicenter, randomized, double-blind study. There are three dosage groups: Hemay005 45 mg BID group, 60 mg BID group or placebo group, with 36 patients in each dosage group. All patients will enter a 12-week double-blind treatment period. All subjects who have received the investigational drug should be subjected to a 4-week observation after the end of treatment.
Detailed Description
This study adopts a multicenter, randomized, double-blind, low--high dose groups and placebo parallel controlled clinical study design. After screening, patients with active ulcerative colitis who meet the inclusion criteria and do not meet the exclusion criteria will be randomized by 1:1:1 to Hemay005 45 mg BID group, 60 mg BID group or placebo group, with proposed 36 patients in each group. All patients will enter a 12-week double-blind inductive treatment period. All randomized subjects who have received the investigational drug should be subjected to a 4-week observation after the end of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hemay005 45 mg BID group
Arm Type
Experimental
Arm Description
3 tablets of Hemay005 (15mg/tablet) and 1 tablet of Hemay005 placebo will be orally administered twice daily.
Arm Title
Hemay005 60 mg BID group
Arm Type
Experimental
Arm Description
4 tablets of Hemay005 (15mg/tablet) will be orally administered twice daily.
Arm Title
Hemay005 placebo BID group
Arm Type
Placebo Comparator
Arm Description
4 tablets of Hemay005 placebo will be orally administered twice daily.
Intervention Type
Drug
Intervention Name(s)
Hemay005 tablets
Other Intervention Name(s)
Hemay005 45 mg BID group
Intervention Description
Hemay005 tablets (15mg/tablet)will be orally administered twice daily.
Intervention Type
Drug
Intervention Name(s)
Hemay005 placebo tablets
Other Intervention Name(s)
Hemay005 placebo BID group
Intervention Description
Hemay005 placebo tablets will be orally administered twice daily.
Primary Outcome Measure Information:
Title
clinical remission
Description
Definition of clinical remission rate: defined as a Mayo score of 0 or 1 in the number of bowel movements with a ≥1 reduction from baseline, a blood in the stool score of 0, and an endoscopic score of 0 or 1 (no fragility).
Time Frame
12 week
Secondary Outcome Measure Information:
Title
clinical response
Description
Definition of clinical response: defined as a Mayo score reduction of ≥2 points from baseline and a decrease of ≥30% from baseline, with a reduction of ≥1 point from baseline in the rectal bleeding sub-score, or a rectal bleeding sub-score of ≤1 point.
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Willing to participate in the trial and signing the informed consent forms; Age ≥18 years old, male or female; Diagnosed as ulcerative colitis (UC) ≥ 3 months at screening with clinical manifestations and evidence of endoscopy and confirmed by histopathological reports; Expansion of the affected bowel segment beyond the rectum confirmed on endoscopy (affected bowel segment≥15cm); Moderate to severe ulcerative colitis with Modified Mayo clinical score (MMCS)≥ 4 points and ≤9 points, the Endoscopy subscore ≥ 2 points within 14 days before randomization and Stool Frequency subscore ≥ 1 point; UC treatment failure or intolerance (intolerance is defined as the discontinuation of drug use due to adverse reactions judged by the investigators) experienced by patients using at least one of the following: Oral administration of sulfasalazine (SASP) and/or 5-aminosalicylic acid (5-ASA); Oral administration of corticosteroids; Azathioprine or 6-mercaptopurine; Anti-TNF-α treatment: infliximab or adalimumab, etc.; - If the patient is using the following drugs to treat ulcerative colitis at the time of screening, it is necessary to receive stable treatment during the screening period and the following requirements during the study period are as follows: Oral administration of sulfasalazine (SASP) and/or 5-aminosalicylic acid (5-ASA) maintaining stable for at least ≥ 2 weeks prior to endoscopy during the screening period and maintaining stable during the study period; and/or Oral administration of low-dose corticosteroids (≤25 mg/d prednisolone or equivalent drug dose) maintaining stable for at least ≥ 2 weeks prior to endoscopy during the screening period; - At least one of the following effective contraceptive methods should be adopted for female patients with fertility and male patients who have not undergone vasectomy during the entire study period from the date of signing the informed consent to 3 months after the last dose. Acceptable contraceptive methods in this study include: a. abstinence; b. hormones (oral intake, patch, ring, injection, implantation) combined with male condoms. This measure must be applied at least 30 days prior to the first administration of investigational drug, otherwise another acceptable method of contraception must be used; c. intra-uterine device (IUD) combined with male condoms; d. barrier method (diaphragm, cervical cap, sponge) combined with male condoms; exceptional circumstances: a) females who have been menopausal for 5 years and more, and b) surgical sterilization (proof should be provided). Exclusion Criteria: Pregnant or lactating women, or women or men whose partners planning to become pregnant during the study; Knownto be allergic to any component of Hemay005 tablets (the main component is hemay005, and the main excipients are mannitol, low substituted hydroxypropyl cellulose, croscarmellose sodium and magnesium stearate); Patients with suspected or confirmed Crohn's disease, undiagnosed types of colitis, fulminant colitis, toxic megacolon, microscopic colitis, ischemic colitis or radioactive colitis based on medical history and endoscopy and/or histological results; Patients with active EBV and/or CMV infection (EBV antibody IgM and/or EBV DNA positive); CMV antibody IgM and/or CMV DNA positive); Patients with the disease confined to the rectum (ulcerative proctitis) according to the endoscopy during screening; Patients who have undergone surgical treatment for ulcerative colitis or who require surgery during the study; Patients with active infection or positive pathogen test at the time of screening, and determined by the investigator to increase the risk of the subject, except for those with negative repeat test results and no symptoms of persistent infection (if time permits, during screening treatment and repeat testing); Patients receiving the following treatments: Patients who have used azathioprine/6-mercaptopurine, methotrexate within 7 days before randomization; Patients who have used cyclosporine, mycophenolate mofetil, tacrolimus/sirolimus within 4 weeks before randomization; Patients who have used interferon within 8 weeks before randomization; Patients who have received anti-TNF-α treatment within 8 weeks before randomization; Intravenous corticosteroids or rectal administration of corticosteroids or rectal administration of 5-ASA within 2 weeks prior to randomization; Patients who have used thalidomide within 8 weeks before randomization;Patients who have received antibiotic treatment within 1 week before randomization; Patients with active infection and judged by the investigator to increase the risk of the subjects; Patients with a history of TB or active TB (Investigator-judged signs or symptoms of active tuberculosis at screening): Screening was permitted if patients had a history of tuberculosis and had been cured by investigator assessment for at least 3 years prior to randomization; subjects with a negative T-cell test for tuberculosis infection (T-SPOT) at screening can be included in this study. Subjects who are T-SPOT positive during the screening period need to undergo tuberculosis-related clinical examinations (Tuberculosis-related clinical work performed within 12 weeks prior to randomization can be used directly for evaluation), if the tuberculosis-related clinical examination confirmed active tuberculosis, the subjects will not be eligible for this study. Subjects can be included in this study if the tuberculosis-related clinical examination confirms inactive tuberculosis. If the research center cannot perform T-SPOT test, TB screening by QuantiFERON-TB Gold test kit can also be accepted. The treatment of QuantiFERON-TB-Gold screening results is the same as that of T-SPOT. Patients with hemoglobin <8 g/dL or hematocrit <30%, white blood cells <3.0 × 10^9/L or neutrophils <1.2 × 10^9/L, platelets <100 × 10^09/L at screening; Total bilirubin (TBIL), aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 upper limits of normal (ULN) at screening; Glomerular filtration rate (eGFR) ≤ 40 ml/min; Patients with hereditary immunodeficiency disease; Patients with a history of lymphoproliferative disorders (e.g. EBV-related lymphoproliferative disorders), or with lymphoma, leukemia, myeloproliferative disease, multiple myeloma; Lymphocyte apheresis or selective mononuclear granulocyte apheresis was performed within 12 months before the screening or is planned to be performed during the study; Patients with malignant tumor or with a history of malignancy other than well-treated or resected basal cell or squamous cell skin cancer; Patients with conditions that may affect oral drug absorption, e.g. gastrectomy or clinically significant diabetes-related gastrointestinal disorders, or specific types of obesity surgery such as gastric bypass, however, patients only subjected to the division of the stomach into independent chambers, like gastric banding, will not be excluded; Patients with previous surgery on small intestine or colon and with evidence of colonic dysplasia or intestinal stenosis; Patients with chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) and hepatitis B core antibody (HBcAb) should be assessed for all patients during screening: patients with positive hepatitis B surface antigen (HBsAg) will be excluded; patients with HBsAg (negative), HBsAb (negative or positive) and HBcAb (positive) should be tested for HBV-DNA, and if the HBV-DNA result is positive, patient will be excluded; if the HBV-DNA result is negative, patients can be enrolled in the study.), chronic hepatitis C virus (HCV) infection (patients with positive hepatitis C virus antibody (HCVAb) excluded) or human immunodeficiency virus (HIV) infection (patients with positive human immunodeficiency virus (HIV) antibody excluded) or Syphilis (TP) infection (excluded patients with Treponema pallidum antibody (Anti-TP) positive); Patients receive any live vaccine at present or has received any live vaccine within 8 weeks prior to randomization, or have been vaccinated against COVID-19 within 14 days prior to randomization; Use of cytochrome P450 enzyme inducers (such as rifampicin, phenobarbital, dexamethasone, isoniazid, carbamazepine, etc.) within 14 days before screening; Suicidal behavior (including active attempts, interrupted attempts, or attempted attempts) or suicidal thoughts within the past 6 months; Other conditions that the investigator judges as unsuitable to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yueying Zhen, Ph.D.
Phone
86-22-24929366
Email
zhenyueying@hemay.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shutian Zhang, MD
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fourth Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Tang, MD
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengdang Wang, MD
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Yang, MD
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bingrong Liu, MD
Facility Name
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohua Hou, MD
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaowei Liu, M.D.
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youxiang Chen, MD
Facility Name
Shengjing Hospital Affiliated to China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Tian
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiuli Zuo, MD
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongwei Xu, M.D.
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liangping Li, MD
Facility Name
First Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Yu, MD
Facility Name
Beijing Chaoyang Hospital Affiliated to Capital Medical University
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyu Hao, MD
Facility Name
Beijing Friendship Hospital Affiliated to Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shutian Zhang, M.D.
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Gu, M.D.
Facility Name
Chongqing People's Hospital
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Guo, MD
Facility Name
Shanghai Oriental Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Zhong, MD
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bangmao Wang, M.D.

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis

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