A Phase 2 interventional study of telotristat ethyl in Biliary Tract Cancer (BTC), sponsored by TerSera Therapeutics LLC. Terminated at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by TerSera Therapeutics LLC · Phase 2, Interventional, and Treatment
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy (cisplatin [cis] plus gemcitabine [gem])
A Phase 2, multicenter, open-label, 2-stage study to assess the safety, tolerability, and efficacy of XERMELO in combination with first-line (1L) therapy cis plus gem in patients with unresectable, locally advanced, recurrent or metastatic biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer), who are naïve to tumor-directed therapy in the locally advanced or metastatic setting, and for which treatment with 1L therapy (defined as a combination of cis plus gem) is planned.
484 studies on the registry are indexed under Biliary Tract Neoplasms; 187 are open to participants now.
This study's enrollment of 53 is close to the median of 56 across 404 interventional studies indexed under Biliary Tract Neoplasms.
Browse Biliary Tract Neoplasms studies →TerSera Therapeutics LLC is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Xermelo 250 milligram (mg) plus first line therapy for a week, then Xermelo 500mg plus first line therapy for the duration of the study
Drug: telotristat ethyl
XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) three times a day plus first line therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) three times a day plus first line therapy for the duration of the study
Also known as: telotristat ethyl + (cisplatin [cis] plus gemcitabine [gem])
Number of Participants With Progression-free Survival (PFS) as Evaluated by Central Radiologist's Assessment
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.
Time frame: Month 6
Project Overall Survival Rate at Month 6
Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6.
Time frame: 6 Months
Overall Survival (OS)
Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause.
Time frame: First dose of study treatment until the date of death due to any cause, whichever came first, a median of approximately 17.67 months
Project Overall Survival Rate at Month 12
Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12.
Time frame: 12 Months
Median Progression Free Survival
Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.
Time frame: Month 12
Disease Control Rate (DCR), Central Radiologist's Assessment
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
Time frame: Month 6
Disease Control Rate (DCR), Central Radiologist's Assessment
Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
Time frame: Month 12
Disease Control Rate (DCR), Central Radiologist's Assessment
Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
Time frame: End of Study up to 24 months
Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. (CR) + partial response (PR) at Months 6
Time frame: Month 6
Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment
Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12.
Time frame: Month 12
Overall (Objective) Response Rate, Central Radiologist's Assessment
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.
Time frame: End of Study as defined up to 24 months
Summary of Duration of Progression Free Survival, Local Radiologist's Assessment
Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months.
Time frame: up to 7 months
Progression Free Survival, Local Radiologist's Assessment
Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.
Time frame: Month 12
Progression Free Survival, Local Radiologist's Assessment
Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study
Time frame: End of Study as defined up to 24 months
Overall (Objective) Response Rate, Local Read
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6.
Time frame: 6 Months
Overall (Objective) Response Rate, Local Reader's Assessment
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12.
Time frame: 12 Months
Overall (Objective) Response Rate (ORR), Local Reader's Assessment
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.
Time frame: End of Study as defined up to 24 months
Disease Control Rate (DCR), Local Reviewer
Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
Time frame: Month 12 as defined by 1 year
Disease Control Rate (DCR), Local Reviewer
Disease control rate (DCR), Local Reviewer, 6 Months
Time frame: Month 6
Disease Control Rate End of Study, Local Reviewer
Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
Time frame: End of Study as defined up to 24 months
Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
Mean change from Baseline to Month 6 plasma level 5-hydroxyindoleacetic acid (5-HIAA)
Time frame: Month 6
Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
Mean change from Baseline to Month 12 in plasma level 5-hydroxyindoleacetic Acid (5-HIAA)
Time frame: Month 12
Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA)
Mean change from Baseline to End of Study in plasma 5-hydroxyindoleacetic acid (5-HIAA)
Time frame: End of Study as defined up to 24 months
Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)
Mean change from Baseline to month 6 in plasma carbohydrate antigen 19-9 (CA 19-9)
Time frame: Month 6
Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9)
Mean change from Baseline to Month 12 in plasma carbohydrate antigen 19-9 (CA 19-9)
Time frame: Month 12
Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9)
Mean change from Baseline to End of Study in plasma carbohydrate antigen 19-9 (CA 19-9)
Time frame: End of Study as defined up to 24 months
Weight Change From Baseline
Mean change in weight at Month 6 from baseline measurement
Time frame: Month 6
Weight Change From Baseline
Mean change in weight at Month 12 from baseline measurement
Time frame: Month 12
Weight Change From Baseline
Mean change in weight from baseline to End of Study
Time frame: End of Study as defined up to 24 months
Change From Baseline in Serum Albumin
Mean change from Baseline to Month 6 serum albumin levels
Time frame: Month 6
Change From Baseline in Serum Albumin
Mean change from Baseline to Month 12 serum albumin levels
Time frame: Month 12
Change From Baseline in Serum Albumin
Mean change from Baseline to End of Study serum albumin levels
Time frame: End of Study as defined up to 24 months
| Milestone | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Started | 53 |
| Completed | 0 |
| Not completed | 53 |
| Withdrew: Study did not meet its primary endpoint. | 53 |
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate.
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Safety Population — Responders, Central Reviewer | 12 |
| Safety Population — Non-Responders, Central Reviewer | 41 |
| Per Protocol Population — Responders, Central Reviewer | 12 |
| Per Protocol Population — Non-Responders, Central Reviewer | 30 |
| By Treatment Cycle Population — Responders, Central Reviewer | 12 |
| By Treatment Cycle Population — Non-Responders, Central Reviewer | 21 |
Overall Survival (OS) was defined as the time from the frist dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring- date of First dose +1). Use Kaplan Meier method to project survival rate at month 6.
| Proportion of participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Project Overall Survival Rate at Month 6 | 0.87 (0.74 to 0.93) |
Overall Survival (OS) was defined as the time from first dose of study treatment until the date of death due to any cause.
| Months | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Overall Survival (OS) | 17.667 (11.567 to NA) |
Overall Survival (OS) was defined as the time from the first dose of study treatment until the date of death due to any cause. Duration of Overall Survival (OS) in days is defined as (Date of event/censoring - date of first dose +1). Use Kaplan Meier method to project survival rate at month 12.
| Proportion of participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Project Overall Survival Rate at Month 12 | 0.60 (0.45 to 0.72) |
Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.
| Months | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Median Progression Free Survival | 6.233 (4.067 to 7.467) |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.".
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Disease Control Rate (DCR), Central Radiologist's Assessment | 33 |
Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Disease Control Rate (DCR), Central Radiologist's Assessment | 33 |
Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Disease Control Rate (DCR), Central Radiologist's Assessment | 35 |
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation. (CR) + partial response (PR) at Months 6
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment | 7 |
Overall response rate (ORR) was defined as the proportion of patients (Number of Responders) with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until Month 12.
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Overall (Objective) Response Rate (ORR), Central Radiologist's Assessment | 7 |
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Overall (Objective) Response Rate, Central Radiologist's Assessment | 7 |
Summary of Duration of Median Progression Free Survival, Local Radiologist's Assessment. Patient progression was defined from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 months.
| Months | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Summary of Duration of Progression Free Survival, Local Radiologist's Assessment | 7.000 (5.567 to NA) |
Summary of Median Progression Free Survival, Local Radiologist's Assessment. Defined as the time from first dose of study treatment until the first date of either disease progression or death due to any cause. Scheduled disease assessment at Cycle 19 Day 1 was used to determine PFS response rate at Month 12.
| Months | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Progression Free Survival, Local Radiologist's Assessment | 7.467 (5.567 to 10.533) |
Summary of Median Progression Free Survival, Local Radiologist's Assessment, End of Study
| Months | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Progression Free Survival, Local Radiologist's Assessment | 7.467 (5.567 to 10.533) |
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 6.
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Overall (Objective) Response Rate, Local Read | 6 |
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment at Month 12.
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Overall (Objective) Response Rate, Local Reader's Assessment | 8 |
Overall response rate (ORR) was defined as the proportion of patients with best overall response of confirmed PR or confirmed CR. The best overall response was the best overall response recorded from the start of study treatment until the EOS considering any requirement for confirmation.
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Overall (Objective) Response Rate (ORR), Local Reader's Assessment | 8 |
Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Disease Control Rate (DCR), Local Reviewer | 40 |
Disease control rate (DCR), Local Reviewer, 6 Months
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Disease Control Rate (DCR), Local Reviewer | 40 |
Disease control rate (DCR) was defined as the proportion of patients with best overall response of SD longer than 6 weeks from first dosing, confirmed PR, or confirmed CR.
| Participants | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Disease Control Rate End of Study, Local Reviewer | 40 |
Mean change from Baseline to Month 6 plasma level 5-hydroxyindoleacetic acid (5-HIAA)
| micrograms/Liter | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA) | -1.735 ± 8.6933 |
Mean change from Baseline to Month 12 in plasma level 5-hydroxyindoleacetic Acid (5-HIAA)
| micrograms/Liter | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA) | -5.608 ± 6.5192 |
Mean change from Baseline to End of Study in plasma 5-hydroxyindoleacetic acid (5-HIAA)
| micrograms/Liter | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Mean Change From Baseline in Plasma 5-hydroxyindoleacetic Acid (5-HIAA) | 4.154 ± 5.7003 |
Mean change from Baseline to month 6 in plasma carbohydrate antigen 19-9 (CA 19-9)
| U/mL | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9) | -229.82 ± 2484.902 |
Mean change from Baseline to Month 12 in plasma carbohydrate antigen 19-9 (CA 19-9)
| U/mL | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Change From Baseline in Carbohydrate Antigen 19-9 (CA 19-9) | -18.04 ± 38.665 |
Mean change from Baseline to End of Study in plasma carbohydrate antigen 19-9 (CA 19-9)
| Units per milliliter | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Change From Baseline in Plasma Carbohydrate Antigen 19-9 (CA 19-9) | -153.98 ± 456.210 |
Mean change in weight at Month 6 from baseline measurement
| kg | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Weight Change From Baseline | -0.69 ± 9.759 |
Mean change in weight at Month 12 from baseline measurement
| kg | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Weight Change From Baseline | 1.69 ± 7.473 |
Mean change in weight from baseline to End of Study
| kg | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Weight Change From Baseline | -3.28 ± 8.920 |
Mean change from Baseline to Month 6 serum albumin levels
| g/L | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Change From Baseline in Serum Albumin | -0.2 ± 4.59 |
Mean change from Baseline to Month 12 serum albumin levels
| g/L | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Change From Baseline in Serum Albumin | -2.2 ± 2.86 |
Mean change from Baseline to End of Study serum albumin levels
| g/L | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Change From Baseline in Serum Albumin | -1.2 ± 4.99 |
Collected over 2 years. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg | 3/53 (5.7%) | 24/53 (45.3%) | 53/53 (100%) |
| Event | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Gastrointestinal disordersGastrointestinal disorders | 8/53 |
| Infections and infestationsInfections and infestations | 5/53 |
| Respiratory, Thoracic and mediastinal disordersRespiratory, thoracic and mediastinal disorders | 5/53 |
| Hepatobiliary disordersHepatobiliary disorders | 3/53 |
| Nervous system disordersNervous system disorders | 3/53 |
| Cardiac DisordersCardiac disorders | 2/53 |
| InvestigationsInvestigations | 2/53 |
| Blood and lymphatic system disordersBlood and lymphatic system disorders | 1/53 |
| Injury, poisoning and procedural complicationsInjury, poisoning and procedural complications | 1/53 |
| Metabolism and nutrition disordersMetabolism and nutrition disorders | 1/53 |
| Event | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| ConstipationGastrointestinal disorders | 34/53 |
| NauseaGastrointestinal disorders | 33/53 |
| FatigueGeneral disorders | 32/53 |
| AnemiaBlood and lymphatic system disorders | 27/53 |
| Neutrophil count decreasedBlood and lymphatic system disorders | 22/53 |
| Platelet count decreasedBlood and lymphatic system disorders | 19/53 |
| DiarrheaGastrointestinal disorders | 18/53 |
| VomitingGastrointestinal disorders | 17/53 |
| White blood cell count decreasedBlood and lymphatic system disorders | 14/53 |
| Abdominal painGastrointestinal disorders | 14/53 |
Safety Population
| Age, Categorical(Participants) | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 22 |
| >=65 years | 31 |
| Age, Continuous(Years) | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Mean | 63.4 ± 10.96 |
| Sex: Female, Male(Participants) | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Female | 33 |
| Male | 20 |
| Ethnicity (NIH/OMB)(Participants) | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 50 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 46 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| United States | 53 |
| Height(inches) | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Mean | 66.4 ± 3.37 |
| Weight(kilogram) | Xermelo 250mg Plus 1L Therapy for a Week, Then Xermelo 500mg |
|---|---|
| Mean | 81.9 ± 17.40 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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TerSera Therapeutics LLC