Clinical trial

An Open-Label, Extension Study of Teduglutide in Japanese Subjects With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

ID

Name

SHP633-307

Description

The purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in Japanese participants with PN/IV (parenteral nutrition/intravenous)-dependent SBS (short bowel syndrome) who completed SHP633-306 or who were in the extension phase of the TED-C14-004 (NCT02340819) study.

Trial arms

Trial start

2018-07-09

Estimated PCD

2022-01-13

Trial end

2022-01-13

Status

Completed

Phase

Early phase I

Treatment

Teduglutide

Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.

Arms:

Teduglutide 0.05 mg

Syringe

Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.

Arms:

Teduglutide 0.05 mg

Needle

Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.

Arms:

Teduglutide 0.05 mg

Vial Adapter for Device

Vial adapter for device is approved for use in Japan by PMDA.

Arms:

Teduglutide 0.05 mg

Size

11

Primary endpoint

Number of Participants Who Demonstrated at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume

Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Change From Baseline in Weekly PS Volume

Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Percent Change From Baseline in Weekly PS Volume

Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Number of Participants Who Were Completely Weaned Off PS at End of Study (EOS)

From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)

Change From Baseline in Days Per Week of PS

Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Change From Baseline in Plasma Citrulline Levels

Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)

Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Values

Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Number of Participants With Clinically Significant Change From Baseline in Vital Sign Measurements

Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Number of Participants With Clinically Significant Change From Baseline in Laboratory Values

Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Number of Participants Who Reported Positive Specific Antibodies to Teduglutide at EOS

From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)

Change From Baseline in 48-Hour Urine Output

Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Number of Participants With Clinically Significant Change From Baseline in Body Weight Measurements

Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Number of Participants With Clinically Significant Change From Baseline in BMI

Baseline (core study) up to approximately 40.2 months (duration of assessment in the current study)

Number of Participants With Clinically Significant Colonoscopy/Sigmoidoscopy Results

From the first dose of study drug (in current study) up to EOS (up to approximately 42 months)

Eligibility criteria

Inclusion Criteria: Participants who meet all of the following criteria will be enrolled in this study: 1. Ability to voluntarily provide written, signed, and informed consent to participate in the study. 2. Completion of the SHP633-306 study or participation in TED-C14-004 (NCT02340819) Stage 3 or Stage 4. 3. Females of childbearing potential must agree to comply with the contraceptive requirements of the protocol. 4. An understanding, ability, and willingness to fully comply with study procedures and restrictions. Exclusion Criteria: There are no exclusion criteria for this study.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}

Updated at

2023-03-15

1 organization

1 product

1 indication

Organization

Product

Indication

Short Bowel Syndrome