Trial · NCT05543174
A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS)
NCT05543174, Phase 3, Completed, Takeda; results first posted 2024-10-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS). Trials, record NCT05543174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05543174
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS)
- NCT number
- NCT05543174
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Alagille Syndrome (ALGS)
- Interventions
- TAK-625
- First posted
- 2022-09-16
- Last updated
- 2026-01-29
- Results first posted
- 2024-10-15
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Fasting Serum Bile Acid (sBA) Levels From Week 18 to Week 22 | From Week 18 to Week 22 | Change in fasting sBA levels from Week 18 to 22 was reported. Change was calculated as: observed value at Week 22- observed value at Week 18. |
| Secondary | Change in Fasting sBA Levels From Baseline to Week 18 | Baseline to Week 18 | Change in fasting sBA levels from baseline to Week 18 was reported. Change was calculated as: observed value at Week 18 - observed value at baseline (before dosing). |
| Secondary | Change in Weekly Average Severity of Pruritus Measured by Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) From Baseline to Week 18 | Baseline to Week 18 | The ItchRO (Obs) scale measures severity of pruritus. The score on ItchRO (Obs) scale ranged from 0 to 4, where 0=None observed or reported, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe. A higher score indicated more severe pruritus. Weekly average severity of Pruritus is calculated based on daily maximum of morning and evening severity scores measured by ItchRO (Obs). Weekly average severity was calculated as the average of the daily maximum of morning and evening over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 18 (Day 120 to Day 126) - average value of baseline (Day -7 to Day -1). |
| Secondary | Change in Weekly Average Morning Severity of Pruritus Measured by Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) From Baseline to Week 18 | Baseline to Week 18 | The ItchRO (Obs) scale measures severity of pruritus. The score on ItchRO (Obs) scale ranged from 0 to 4, where 0=None observed or reported, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe. A higher score indicated more severe pruritus. Weekly average morning severity was calculated as the average of the daily morning scores over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 18 (Day 120 to Day 126) - average value of baseline (Day -7 to Day -1). |
| Secondary | Change in Weekly Average Severity of Pruritus Measured by ItchRO (Obs) From Week 18 to Week 22 | From Week 18 to Week 22 | The ItchRO (Obs) scale measures severity of pruritus. The score on ItchRO (Obs) scale ranged from 0 to 4, where 0=None observed or reported, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe. A higher score indicated more severe pruritus. Weekly average severity of Pruritus was calculated based on daily maximum of morning and evening severity scores measured by ItchRO (Obs). Weekly average severity were calculated as the average of the daily maximum of morning and evening over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 22 (Day 148 to Day 154) - average value of Week 18 (Day 120 to Day 126). |
| Secondary | Change in Weekly Average Morning Severity of Pruritus Measured by ItchRO (Obs) From Week 18 to Week 22 | From Week 18 to Week 22 | The ItchRO (Obs) scale measures severity of pruritus. The score on ItchRO (Obs) scale ranged from 0 to 4, where 0=None observed or reported, 1=Mild, 2=Moderate, 3=Severe, 4=Very severe. A higher score indicated more severe pruritus. Weekly average morning severity was calculated as the average of the daily morning scores over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 22 (Day 148 to Day 154) - average value of Week 18 (Day 120 to Day 126). |
| Secondary | Change in Weekly Average Severity of Pruritus Measured by ItchRO (Pt) From Baseline to Week 18 | Baseline to Week 18 | The ItchRO (Pt) scale measures severity of pruritus. The score on ItchRO (Pt) scale ranged from 0 to 4, where 0= Not felt itchy, 1= Felt a little bit itchy, 2= Felt pretty itchy, 3= Felt very itchy, 4= Felt very, very itchy. A higher score indicated more severe pruritus. Weekly average severity of Pruritus was calculated based on daily maximum of morning and evening severity scores measured by ItchRO (Pt). Weekly average scores was calculated as the average of the daily maximum of morning and evening over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 18 (Day 120 to Day 126) - average value of baseline (Day -7 to Day -1). |
| Secondary | Change in Weekly Average Morning Severity of Pruritus Measured by ItchRO (Pt) From Baseline to Week 18 | Baseline to Week 18 | The ItchRO (Pt) scale measures severity of pruritus. The score on ItchRO (Pt) scale ranged from 0 to 4, where 0= Not felt itchy, 1= Felt a little bit itchy, 2= Felt pretty itchy, 3= Felt very itchy, 4= Felt very, very itchy. A higher score indicated more severe pruritus. Weekly average morning severity was calculated as the average of the daily morning scores over the visit consisting of the 7 days on or before the scheduled Study Day (i.e., the sum of the scores divided by the number of non-missing scores). Change was calculated as: average value of Week 18 (Day 120 to Day 126) - average value of baseline (Day -7 to Day -1). |
| Secondary | Change in Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels From Baseline to Week 18 | Baseline to Week 18 | Change in ALT and ALP levels from baseline to Week 18 were reported. Change was calculated as: observed value at Week 18 - observed value at baseline (before dosing). |
| Secondary | Change in Bilirubin (Total and Direct) Levels From Baseline to Week 18 | Baseline to Week 18 | Change in bilirubin (total and direct) from baseline to Week 18 was reported. Change was calculated as: observed value at Week 18 - observed value at baseline (before dosing). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Fasting Serum Bile Acid (sBA) Levels From Week 18 to Week 22 | From Week 18 to Week 22 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | micromoles per liter (mcmol/L) | MEAN |
| SECONDARY | Change in Fasting sBA Levels From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | mcmol/L | MEAN |
| SECONDARY | Change in Weekly Average Severity of Pruritus Measured by Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | score on a scale | MEAN |
| SECONDARY | Change in Weekly Average Morning Severity of Pruritus Measured by Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | score on a scale | MEAN |
| SECONDARY | Change in Weekly Average Severity of Pruritus Measured by ItchRO (Obs) From Week 18 to Week 22 | From Week 18 to Week 22 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | score on a scale | MEAN |
| SECONDARY | Change in Weekly Average Morning Severity of Pruritus Measured by ItchRO (Obs) From Week 18 to Week 22 | From Week 18 to Week 22 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | score on a scale | MEAN |
| SECONDARY | Change in Weekly Average Severity of Pruritus Measured by ItchRO (Pt) From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change in Weekly Average Morning Severity of Pruritus Measured by ItchRO (Pt) From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. Here, overall number of participants analyzed signified those participants who were evaluable for this outcome measure. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | score on a scale | MEAN |
| SECONDARY | Change in Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | Units per liter (U/L) | MEAN |
| SECONDARY | Change in Bilirubin (Total and Direct) Levels From Baseline to Week 18 | Baseline to Week 18 | ITT included all participants who received at least one dose of study drug. As per-planned analysis, the data for outcome measure were collected, analyzed and reported as a single cohort. | mcmol/L | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Fasting Serum Bile Acid (sBA) Levels From Week 18 to Week 22 | TAK-625 | 17.643 | 95% Confidence Interval -31.6389 to 66.9246 | micromoles per liter (mcmol/L) | |
| Change in Fasting sBA Levels From Baseline to Week 18 | TAK-625 | 8.300 | 95% Confidence Interval -37.4110 to 54.0110 | mcmol/L | |
| Change in Weekly Average Severity of Pruritus Measured by Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) From Baseline to Week 18 | TAK-625 | -1.531 | 95% Confidence Interval -2.3405 to -0.7208 | score on a scale | |
| Change in Weekly Average Morning Severity of Pruritus Measured by Itch Reported Outcome (ItchRO) (Observer Instrument [Obs]) From Baseline to Week 18 | TAK-625 | -1.327 | 95% Confidence Interval -2.1071 to -0.5460 | score on a scale | |
| Change in Weekly Average Severity of Pruritus Measured by ItchRO (Obs) From Week 18 to Week 22 | TAK-625 | -0.286 | 95% Confidence Interval -0.6594 to 0.0880 | score on a scale | |
| Change in Weekly Average Morning Severity of Pruritus Measured by ItchRO (Obs) From Week 18 to Week 22 | TAK-625 | -0.280 | 95% Confidence Interval -0.6769 to 0.1163 | score on a scale | |
| Change in Weekly Average Severity of Pruritus Measured by ItchRO (Pt) From Baseline to Week 18 | TAK-625 | -1.381 | 95% Confidence Interval -5.0058 to 2.2439 | score on a scale | |
| Change in Weekly Average Morning Severity of Pruritus Measured by ItchRO (Pt) From Baseline to Week 18 | TAK-625 | -1.238 | 95% Confidence Interval -3.6537 to 1.1775 | score on a scale | |
| Change in Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels From Baseline to Week 18 | TAK-625 | Change in ALT | 17.7 | 95% Confidence Interval -52.66 to 88.09 | Units per liter (U/L) |
| Change in Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP) Levels From Baseline to Week 18 | TAK-625 | Change in ALP | 75.6 | 95% Confidence Interval -186.50 to 337.64 | Units per liter (U/L) |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAK-625 | 7 | |
| Overall Study | Dosed TAK-625 200 mcg/kg | TAK-625 | 7 | |
| Overall Study | Dosed TAK-625 400 mcg/kg | TAK-625 | 7 | |
| Overall Study | COMPLETED | TAK-625 | 6 | |
| Overall Study | NOT COMPLETED | TAK-625 | 1 |
Source ClinicalTrials.gov
Adverse events34
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Administration site extravasation | General disorders | TAK-625 | 1 | 7 | |
| other | Alanine aminotransferase increased | Investigations | TAK-625 | 2 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | TAK-625 | 1 | 7 | |
| other | Anal rash | Gastrointestinal disorders | TAK-625 | 1 | 7 | |
| other | Arthropod bite | Injury, poisoning and procedural complications | TAK-625 | 1 | 7 | |
| other | Aspartate aminotransferase increased | Investigations | TAK-625 | 1 | 7 | |
| other | Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | TAK-625 | 1 | 7 | |
| other | COVID-19 | Infections and infestations | TAK-625 | 1 | 7 | |
| other | Chapped lips | Gastrointestinal disorders | TAK-625 | 1 | 7 | |
| other | Congenital arterial malformation | Congenital, familial and genetic disorders | TAK-625 | 1 | 7 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAK-625 | 0 | 7 |
| Total, other adverse events | TAK-625 | 7 | 7 |
| Total, serious adverse events | TAK-625 | 1 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05543174
GET https://conductscience.org/api/trials/v1/NCT05543174/events?page=2