Trial Outcomes & Findings for A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788 (NCT NCT04132050)

NCT ID: NCT04132050

Last Updated: 2025-08-11

Results Overview

The percentage of subjects who achieved stable platelet response (defined as a platelet count of ≥50000/μL at 4 or more of the 6 visits from Weeks 14 to 24)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

34 participants

Primary outcome timeframe

24 weeks (Period I)

Results posted on

2025-08-11

Participant Flow

Seventy-two subjects were screened. Of these, 34 subjects considered eligible for the study were randomized to receive the investigational products. The number of subjects in Period I were 22 in the R788 group and 12 in the placebo group. The number of subjects who completed Period I was 10 in the R788 group and 4 in the placebo group.

Participant milestones

Participant milestones
Measure	R788 Group R788 will be administered orally for 24 weeks in the Period I.	Placebo Group R788 placebo will be administered orally for 24 weeks in the Period I.
Period I (Double-blind Period) STARTED	22	12
Period I (Double-blind Period) COMPLETED	10	4
Period I (Double-blind Period) NOT COMPLETED	12	8
R788 Treatment Period STARTED	33	0
R788 Treatment Period COMPLETED	22	0
R788 Treatment Period NOT COMPLETED	11	0

Reasons for withdrawal

Reasons for withdrawal
Measure	R788 Group R788 will be administered orally for 24 weeks in the Period I.	Placebo Group R788 placebo will be administered orally for 24 weeks in the Period I.
Period I (Double-blind Period) Adverse Event	3	0
Period I (Double-blind Period) Lack of Efficacy	9	8
R788 Treatment Period Adverse Event	5	0
R788 Treatment Period Lack of Efficacy	5	0
R788 Treatment Period Withdrawal by Subject	1	0

Baseline Characteristics

A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	R788 Group n=22 Participants R788 will be administered orally for 24 weeks in the Period I.	Placebo Group n=12 Participants R788 placebo will be administered orally for 24 weeks in the Period I.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	59.6 years STANDARD_DEVIATION 15.4 • n=5 Participants	60.8 years STANDARD_DEVIATION 15.4 • n=7 Participants	60.0 years STANDARD_DEVIATION 15.2 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	8 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	12 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	22 Participants n=5 Participants	12 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Japan	22 Participants n=5 Participants	12 Participants n=7 Participants	34 Participants n=5 Participants
Baseline platelet count	19000 cells/μL n=5 Participants	18000 cells/μL n=7 Participants	18000 cells/μL n=5 Participants
Time since ITP diagnosis	12 years n=5 Participants	12 years n=7 Participants	12 years n=5 Participants
History of splenectomy	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Line of Therapy 2	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Line of Therapy ≥3	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks (Period I)

The percentage of subjects who achieved stable platelet response (defined as a platelet count of ≥50000/μL at 4 or more of the 6 visits from Weeks 14 to 24)

Outcome measures

Outcome measures
Measure	R788 Group n=22 Participants R788 will be administered orally for 24 weeks in the Period I.	Placebo Group n=12 Participants R788 placebo will be administered orally for 24 weeks in the Period I.
Achievement Rate of Stable Platelet Response	36.4 Percentage of participants Interval 17.2 to 59.3	0.0 Percentage of participants Interval 0.0 to 26.5

OTHER_PRE_SPECIFIED outcome

Timeframe: R788 treatment period (maximum duration of exposure was 1184 days)

Period from the first measurement day on which a platelet count of ≥50000/μL for at least 28 consecutive days was achieved to the first measurement day on which platelet count fell below 50000/μL for at least 28 consecutive days

Outcome measures

Outcome measures
Measure	R788 Group n=33 Participants R788 will be administered orally for 24 weeks in the Period I.	Placebo Group R788 placebo will be administered orally for 24 weeks in the Period I.
Duration of Platelet Response	392 days Interval 106.0 to 946.0	—

Adverse Events

R788 Group (Period I)

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebe Group (Period I)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

R788 Group (R788 Treatment Period)

Serious events: 8 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	R788 Group (Period I) n=22 participants at risk R788 will be administered orally for 24 weeks. On Day 1, 100 mg of the investigational product will be administered. The dose of 100 mg of the study drug will be administered and this must be the only administration of the study drug on Day 1, irrespective of the time of administration. The investigational product will be administered twice daily beginning on the next day (=100 mg bid). If the platelet count at Week 4 or later is below 50000/μL and the investigational product has been well tolerated, the dose of investigational product will be increased from 100 mg bid to 150 mg bid at the discretion of the investigator. The dose during Period I will be adjusted in accordance with the platelet count and tolerance to the investigational product.	Placebe Group (Period I) n=12 participants at risk R788 placebo will be administered orally for 24 weeks. On Day 1, 100 mg of the investigational product will be administered. The dose of 100 mg of the study drug will be administered and this must be the only administration of the study drug on Day 1, irrespective of the time of administration. The investigational product will be administered twice daily beginning on the next day (=100 mg bid). If the platelet count at Week 4 or later is below 50000/μL and the investigational product has been well tolerated, the dose of investigational product will be increased from 100 mg bid to 150 mg bid at the discretion of the investigator. The dose during Period I will be adjusted in accordance with the platelet count and tolerance to the investigational product.	R788 Group (R788 Treatment Period) n=33 participants at risk * Period I: R788 will be administered orally for 24 weeks as detailed left. * Period II: R788 will be administered orally for 28 weeks. * Period III: R788 will be administered orally until market authorization of R788 in Japan. * Period of post-marketing study: R788 will be administered orally shall be from the date of market authorization of R788 to the date of first scheduled visit after the day on which R788 becomes available for use as a marketed product to the subject. The dose of R788 is adjusted up or down depending on the platelet count within the range of 100 mg qd, 100 mg bid, 150 mg qd, and 150 mg bid.
Infections and infestations COVID-19	0.00% 0/22 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/12 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	3.0% 1/33 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Infections and infestations Cellulitis	0.00% 0/22 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/12 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	3.0% 1/33 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Infections and infestations Gastroenteritis	0.00% 0/22 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/12 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	3.0% 1/33 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Infections and infestations Herpes zoster	0.00% 0/22 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/12 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	3.0% 1/33 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Infections and infestations Pericoronitis	0.00% 0/22 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/12 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	3.0% 1/33 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Blood and lymphatic system disorders Thrombocytopenia	4.5% 1/22 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/12 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	3.0% 1/33 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Cardiac disorders Atrial fibrillation	0.00% 0/22 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/12 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	3.0% 1/33 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Gastrointestinal disorders Diarrhoea	4.5% 1/22 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/12 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	3.0% 1/33 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Gastrointestinal disorders Large intestine polyp	0.00% 0/22 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/12 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	3.0% 1/33 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/22 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/12 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	3.0% 1/33 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/22 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/12 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	3.0% 1/33 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/22 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/12 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	3.0% 1/33 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Hepatobiliary disorders Bile duct stone	0.00% 0/22 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	8.3% 1/12 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/33 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.
Injury, poisoning and procedural complications Procedural haemorrhage	0.00% 0/22 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	8.3% 1/12 • Number of events 1 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.	0.00% 0/33 • - Period I: 24 weeks - R788 treatment period: Period I (24 weeks) + Period II (28 weeks) + Period III (Period III and the period of post-marketing clinical study: Maximum 845 days) Although the time frames are different, the AEs observed in the R788 group and Placebo groups in Period I (double-blind) and the AEs collected from all subjects who received R788 throughout the R788 Treatment Period (double-blind + open-label (including post-marketing study)) are listed in the same table.

Other adverse events

Additional Information

Clinical Development Division

Kissei Pharmaceutical Co., Ltd.

Phone: Email olly

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place