A Phase 3 interventional study of teduglutide in Short Bowel Syndrome, sponsored by Shire. Completed at 23 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-11.
Sponsored by Shire · Phase 3, Interventional, and Treatment
This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.
Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for those effects increases the longer people are on PN.
Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent SBS. Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.
149 studies on the registry are indexed under Short Bowel Syndrome; 25 are open to participants now.
This study's enrollment of 88 is above the median of 20 across 100 interventional studies indexed under Short Bowel Syndrome.
Browse Short Bowel Syndrome studies →Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.05 mg/kg/day
Drug: teduglutide
0.05 mg/kg/day subcutaneously taken once per day for 24 months
Also known as: Gattex
Percent Change in PN/IV Volume by Visit
The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Time frame: 24 months
Absolute Change in PN/IV Volume by Visit
The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
Time frame: 24 months
Number of Subjects Achieving PN/IV Reduction
The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.
Time frame: 24 Months or Last Dosing Visit
Subjects who met any of the following could be enrolled: Completed 24 weeks of treatment in Study CL0600-020; based on PI and sponsor decision, subjects who were required to stop treatment prematurely due to a non drug related AE; or successfully completed Stage I (optimization/stabilization) in Study CL0600-020 after \~86 subjects were randomized
| Milestone | Teduglutide 0.05 mg/kg/Day |
|---|---|
| Started | 88 |
| Completed | 65 |
| Not completed | 23 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Physician decision | 2 |
| Withdrew: Death | 1 |
| Withdrew: Adverse event | 16 |
The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
| percent change | NT/TED | PBO/TED | TED/TED |
|---|---|---|---|
| Month 1 | -5.35 ± 11.287 | -6.44 ± 11.241 | -40.65 ± 21.546 |
| Month 2 | -12.88 ± 22.789 | -10.27 ± 14.027 | -44.24 ± 21.823 |
| Month 3 | -10.83 ± 47.396 | -14.18 ± 16.440 | -45.80 ± 22.681 |
| Month 6 | -24.13 ± 17.496 | -16.48 ± 20.979 | -34.70 ± 55.319 |
| Month 9 | -25.35 ± 17.855 | -20.95 ± 27.500 | -37.91 ± 57.460 |
| Month 12 | -23.33 ± 20.296 | -22.00 ± 33.858 | -51.33 ± 28.299 |
| Month 15 | -31.62 ± 25.901 | -18.89 ± 33.165 | -54.24 ± 27.871 |
| Month 18 | -35.11 ± 35.545 | -24.18 ± 32.183 | -63.01 ± 26.587 |
| Month 21 | -39.40 ± 36.504 | -27.67 ± 33.064 | -64.99 ± 27.920 |
| Month 24 | -39.40 ± 36.504 | -28.33 ± 35.169 | -65.61 ± 33.606 |
The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
| Liters | NT/TED | PBO/TED | TED/TED |
|---|---|---|---|
| Month 1 | -1.05 ± 1.315 | -0.95 ± 1.938 | -5.28 ± 3.819 |
| Month 2 | -1.88 ± 2.057 | -1.38 ± 2.228 | -5.62 ± 3.873 |
| Month 3 | -2.55 ± 3.123 | -1.65 ± 2.456 | -5.72 ± 3.771 |
| Month 6 | -3.85 ± 2.761 | -1.90 ± 3.309 | -5.20 ± 4.650 |
| Month 9 | -3.69 ± 2.916 | -2.61 ± 4.071 | -5.59 ± 4.899 |
| Month 12 | -2.90 ± 2.762 | -2.72 ± 4.310 | -6.36 ± 4.633 |
| Month 15 | -3.58 ± 2.811 | -2.48 ± 4.398 | -6.37 ± 4.261 |
| Month 18 | -3.63 ± 2.834 | -2.90 ± 4.394 | -6.99 ± 4.048 |
| Month 21 | -4.01 ± 2.910 | -3.00 ± 3.571 | -7.34 ± 4.412 |
| Month 24 | -4.01 ± 2.910 | -3.11 ± 3.880 | -7.55 ± 4.930 |
The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.
| participants | NT/TED | PBO/TED | TED/TED |
|---|---|---|---|
| Achieving >= 1 Day of PN/IV Reduction | 3 | 14 | 21 |
| Achieving >= 2 Day of PN/IV Reduction | 2 | 7 | 18 |
| Achieving >= 3 Day of PN/IV Reduction | 2 | 5 | 18 |
Collected over Adverse event data were collected for each subject from the time informed consent was signed to the end of the study. The most commonly reported treatment emergent adverse events (>= 3% grouped at PT level) are listed.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NT,PBO/TED | — | 32/51 (62.7%) | 49/51 (96.1%) |
| TED/TED | — | 24/37 (64.9%) | 35/37 (94.6%) |
| Event | NT,PBO/TED | TED/TED |
|---|---|---|
| Central line infectionInfections and infestations | 3/51 | 5/37 |
| Urinary tract infectionInfections and infestations | 0/51 | 3/37 |
| PyrexiaGeneral disorders | 4/51 | 1/37 |
| Catheter bacteraemiaInfections and infestations | 4/51 | 0/37 |
| Catheter sepsisInfections and infestations | 3/51 | 1/37 |
| SepsisInfections and infestations | 3/51 | 1/37 |
| Catheter related infectionInfections and infestations | 1/51 | 2/37 |
| PneumoniaInfections and infestations | 1/51 | 2/37 |
| Catheter site infectionInfections and infestations | 0/51 | 2/37 |
| GastroenteritisInfections and infestations | 0/51 | 2/37 |
| Event | NT,PBO/TED | TED/TED |
|---|---|---|
| Infections and InfestationsInfections and infestations | 31/51 | 26/37 |
| Gastrointestinal DisordersGastrointestinal disorders | 34/51 | 20/37 |
| General Disorders, and Administration Site ConditionsGeneral disorders | 27/51 | 15/37 |
| InvestigationsInvestigations | 22/51 | 19/37 |
| Metabolism and Nutrition DisorderMetabolism and nutrition disorders | 14/51 | 14/37 |
| Injury, Poisoning, and Procedural ComplicationsInjury, poisoning and procedural complications | 19/51 | 13/37 |
| Musculoskeletal and Connective Tissue DisordersMusculoskeletal and connective tissue disorders | 11/51 | 13/37 |
| Vascular DisorderVascular disorders | 14/51 | 6/37 |
| Nervous System DisordersNervous system disorders | 10/51 | 10/37 |
| Respiratory, Thoracic, and Mediastinal DisordersRespiratory, thoracic and mediastinal disorders | 10/51 | 7/37 |
| Age, Categorical(Participants) | Teduglutide 0.05 mg/kg/Day |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 73 |
| >=65 years | 15 |
| Sex: Female, Male(Participants) | Teduglutide 0.05 mg/kg/Day |
|---|---|
| Female | 47 |
| Male | 41 |
| Years since start of PN/IV dependecy(years) | Teduglutide 0.05 mg/kg/Day |
|---|---|
| Mean | 6.41 ± 6.272 |
| Prescribed weekly PN/IV volume(Liters) | Teduglutide 0.05 mg/kg/Day |
|---|---|
| Mean | 12.07 ± 7.56 |
| Prescribed weekly number of days on PN/IV(days) | Teduglutide 0.05 mg/kg/Day |
|---|---|
| Mean | 5.6 ± 1.68 |
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shire