UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054873 |
|---|---|
| Receipt number | R000062696 |
| Scientific Title | Therapeutic effectiveness and safety of crovalimab, SKY 59, in patients with Paroxysmal Nocturnal Hemoglobinuria: a prospective multi-institutional observational study in Japan |
| Date of disclosure of the study information | 2024/07/05 |
| Last modified on | 2025/07/04 11:27:38 |
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Basic information
Public title
Therapeutic effectiveness and safety of crovalimab, SKY 59, in patients with Paroxysmal Nocturnal Hemoglobinuria: a prospective multi-institutional observational study in Japan
Acronym
ANSHAR study
Scientific Title
Therapeutic effectiveness and safety of crovalimab, SKY 59, in patients with Paroxysmal Nocturnal Hemoglobinuria: a prospective multi-institutional observational study in Japan
Scientific Title:Acronym
ANSHAR study
Region
| Japan |
Condition
Condition
Paroxysmal Nocturnal Hemoglobinuria
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of crovalimab in complement inhibitor-naive/treatment-experienced PNH patients in Japanese clinical setting, and to evaluate changes in protein expression after crovalimab treatment to generate data leading to understand the disease pathophysiology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients who achieved hemolysis control from week 5 to week 25 after starting crovalimab in the complement inhibitor-naive cohort and complement inhibitor-treated cohort.
Key secondary outcomes
Following endpoints for thee complement inhibitor-naive group and complement inhibitor-treated group, from baseline to week 25:
1) Proportion of patients who achieved transfusion avoidance
2) Proportion of patients with stable hemoglobin levels
3) Proportion of patients who experienced breakthrough hemolysis
4) Changes in FACIT-Fatigue scores
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Common inclusion criteria for the complement inhibitor-naive group, complement inhibitor-treated group, and crovalimab treating group:
1.Understand Japanese consent form and consent to participate in the study 2.16 years or older at the time of consent 3.The patient has been diagnosed with PNH
2) Additional inclusion criteria for the complement inhibitor-naive group:
1. No prior treatment with complement inhibitors
2. Crovalimab treatment is planned based on the latest package insert
3) Inclusion criteria for patients in the complement inhibitor-naive group who will also undergo blood sampling and analysis :
1. Meet all selection criteria for the complement inhibitor-naive group
2. Consent to additional blood sampling for this evaluation
3. Not receiving crovalimab at the time of consent
4) Additional selection criteria for the complement inhibitor-treated group:
1. Meet at least one of the following criteria:
a. Have a history of treatment with eculizumab
b. Have a history of treatment with ravulizumab
c. Have a history of treatment with a proximal complement inhibitor
2. Crovalimab treatment is planned based on the latest package insert
5) Inclusion criteria for patients in the complement inhibitor-treated group who will also undergo blood sampling and analysis :
1.
a. Meet all selection criteria for the complement inhibitor-treated group
b. No record of having the Arg885His missense mutation in complement C5
c. Consent to additional blood sampling for this evaluation
d. Not receiving crovalimab at the time of consent
2. Meet at least one of the following criteria:
a. Continued eculizumab for at least 4 weeks until 2 weeks before starting crovalimab
b. Continued ravulizumab for at least 4 weeks until 8 weeks before starting crovalimab
6) Additional selection criteria for the crovalimab treating group:
1. Participated in a clinical trial of crovalimab and switched from the clinical trial to crovalimab treatment in clinical setting
Key exclusion criteria
Common exclusion criteria for the complement inhibitor-naive Group, complement inhibitor-treated group, and crovalimab treating group:
Patients who meet any of the following criteria will be excluded from the study:
1. Have a history or plan for hematopoietic stem cell transplantation
2. Treatment with crovalimab is considered inappropriate according to the package insert
3. Participating or planning to participate in another interventional study or clinical trial
4. Other reasons deemed unsuitable for participation in this study by the principal/sub-investigator
Inclusion/exclusion criteria for the healthy subject group:
Subjects who meet any of the following criteria will be excluded from the study. These items will be confirmed through self-reporting by the subjects:
1. Having uncontrolled hypertension at the time of consent
2. Being under 18 years of age at the time of consent
3. Weighing less than 40 kg at the time of consent
4. Having received treatment for malignancy within the past 104 weeks
5. Being pregnant
6. Having inflammatory conditions such as chronic infectious diseases (e.g., viral hepatitis), autoimmune diseases (e.g., SLE), chronic inflammatory demyelinating diseases (e.g., multiple sclerosis), inflammatory bowel diseases (e.g., ulcerative colitis), or complement-related diseases (e.g., PNH)
7. Having chronic kidney disease or liver disease, chronic heart failure or myocardial infarction diagnosed within the past 12 weeks, or uncontrolled diabetes (HbA1c more than 8% if known)
8. Having an acute viral or bacterial infection or a body temperature exceeding 38C within 24 hours before enrollment
9. Having participated in any therapeutic clinical trial within the past 52 weeks
10. Having taken any medication within the past 7 days
11. Having consumed alcohol within the past 12 hours
12. Having undergone plasma exchange within the past 16 weeks
13. Having received a blood transfusion within the past 52 weeks
Target sample size
89
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Yamashita |
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
Division name
Specialty Medical Science Dept.
Zip code
103-8324
Address
1-1 NIHONBASHI-MUROMACHI, 2-CHOME, CHUO-KU, TOKYO
TEL
03-3273-2613
cma-clinicaltrial@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kondo |
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
Division name
Specialty Medical Science Dept.
Zip code
103-8324
Address
1-1 NIHONBASHI-MUROMACHI, 2-CHOME, CHUO-KU, TOKYO
TEL
03-3273-0866
Homepage URL
kondosts@chugai-pharm.co.jp
Sponsor or person
Institute
CHUGAI PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2030 | Year | 05 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062696
