Trial · NCT01670110
Pasireotide LAR in Severe Polycystic Liver Disease
NCT01670110, Phase 2, Completed, Mayo Clinic; results first posted 2020-03-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pasireotide LAR in Severe Polycystic Liver Disease. Trials, record NCT01670110. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01670110
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pasireotide LAR in Severe Polycystic Liver Disease
- NCT number
- NCT01670110
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Somatostatin Analogs, Polycystic Liver Disease, Autosomal Dominant Polycystic Kidney Disease, Autosomal Dominant Polycystic Liver Disease
- Interventions
- Pasireotide LAR, Placebo
- First posted
- 2012-08-21
- Last updated
- 2020-05-01
- Results first posted
- 2020-03-02
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Liver Volume | baseline , 12 month | Percent change was calculated for liver volumes using the equation=\[(12 month value-baseline value)/baseline value\]\*100\*12/12 month |
| Primary | Change in Kidney Volume | baseline to 12 months | Percent change was calculated for kidney volumes using the equation=\[(12 month value-baseline value)/baseline value\]\*100\*12/12 month |
| Secondary | Percentage Change in Estimated Glomerular Filtration Rate (eGFR) | Baseline, 12 months | eGFR was measured using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. This value at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100 |
| Secondary | Percentage Change in Serum Creatinine | Baseline, 12 months | Serum creatinine level at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100 |
| Secondary | Percent Change in Blood Glucose | Baseline, 12 months | Blood glucose (mg/dLb) level at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100 |
| Secondary | Percentage Change in Hemoglobin A1C | Baseline, 12 months | Hemoglobin A1C level at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100 |
| Secondary | Percentage Change in Heart Rate | Baseline, 12 months | Heart rate, measured in beats per minute (BPM), at baseline and 12 months was used to calculate the percentage change by \[12 month value-baseline value)/baseline value\]\*100 |
| Secondary | Change in Quality of Life | Baseline, 12 months | Measured using the SF-36 health survey, which consist of eight subscales each scored on a range of 0 to 100 (0=worst imaginable, 100=best imaginable). Change calculated from baseline = 12 month value-baseline value |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Liver Volume | baseline , 12 month | percentage of change | MEAN | |
| PRIMARY | Change in Kidney Volume | baseline to 12 months | percentage of change | MEAN | |
| SECONDARY | Percentage Change in Estimated Glomerular Filtration Rate (eGFR) | Baseline, 12 months | percentage of change | MEAN | |
| SECONDARY | Percentage Change in Serum Creatinine | Baseline, 12 months | percentage of change | MEAN | |
| SECONDARY | Percent Change in Blood Glucose | Baseline, 12 months | percentage of change | MEAN | |
| SECONDARY | Percentage Change in Hemoglobin A1C | Baseline, 12 months | percentage of change | MEAN | |
| SECONDARY | Percentage Change in Heart Rate | Baseline, 12 months | percentage of change | MEAN | |
| SECONDARY | Change in Quality of Life | Baseline, 12 months | Data for 19 participants in the pasireotide LAR (SOM230) group and 9 participants from the placebo injection group was available for analysis. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Liver Volume | Pasireotide LAR (SOM230) | -3.36 | Standard Deviation 7.33 | percentage of change | |
| Change in Liver Volume | Placebo Injection | 6.29 | Standard Deviation 6.97 | percentage of change | |
| Change in Kidney Volume | Pasireotide LAR (SOM230) | -1.37 | Standard Deviation 3.52 | percentage of change | |
| Change in Kidney Volume | Placebo Injection | 3.85 | Standard Deviation 4.49 | percentage of change | |
| Percentage Change in Estimated Glomerular Filtration Rate (eGFR) | Pasireotide LAR (SOM230) | -0.3 | Standard Deviation 14 | percentage of change | |
| Percentage Change in Estimated Glomerular Filtration Rate (eGFR) | Placebo Injection | -2.2 | Standard Deviation 17.7 | percentage of change | |
| Percentage Change in Serum Creatinine | Pasireotide LAR (SOM230) | 1.8 | Standard Deviation 12 | percentage of change | |
| Percentage Change in Serum Creatinine | Placebo Injection | 3.4 | Standard Deviation 15.6 | percentage of change | |
| Percent Change in Blood Glucose | Pasireotide LAR (SOM230) | 39 | Standard Deviation 30 | percentage of change | |
| Percent Change in Blood Glucose | Placebo Injection | 2.2 | Standard Deviation 15.2 | percentage of change |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pasireotide LAR (SOM230) | 33 | |
| Overall Study | STARTED | Placebo Injection | 15 | |
| Overall Study | COMPLETED | Pasireotide LAR (SOM230) | 29 | |
| Overall Study | COMPLETED | Placebo Injection | 12 | |
| Overall Study | NOT COMPLETED | Pasireotide LAR (SOM230) | 4 | |
| Overall Study | NOT COMPLETED | Placebo Injection | 3 |
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 | Hyperglycemia | Metabolism and nutrition disorders | Pasireotide LAR (SOM230) | 26 | 33 | 26 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Placebo Injection | 4 | 15 | 4 |
| other | Diarrhea | Gastrointestinal disorders | Pasireotide LAR (SOM230) | 17 | 33 | 17 |
| other | Diarrhea | Gastrointestinal disorders | Placebo Injection | 8 | 15 | 8 |
| other | Dizziness | Nervous system disorders | Pasireotide LAR (SOM230) | 10 | 33 | 10 |
| other | Dizziness | Nervous system disorders | Placebo Injection | 3 | 15 | 3 |
| other | Pain abdomen | Gastrointestinal disorders | Pasireotide LAR (SOM230) | 11 | 33 | 11 |
| other | Pain abdomen | Gastrointestinal disorders | Placebo Injection | 1 | 15 | 1 |
| other | Fatigue | General disorders | Pasireotide LAR (SOM230) | 13 | 33 | 13 |
| other | Fatigue | General disorders | Placebo Injection | 3 | 15 | 3 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pasireotide LAR (SOM230) | 0 | 33 |
| Total, all-cause mortality | Placebo Injection | 1 | 15 |
| Total, other adverse events | Pasireotide LAR (SOM230) | 33 | 33 |
| Total, other adverse events | Placebo Injection | 15 | 15 |
| Total, serious adverse events | Pasireotide LAR (SOM230) | 4 | 33 |
| Total, serious adverse events | Placebo Injection | 1 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32843370 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pasireotide LAR (SOM230) vs Placebo Injection: deaths from any cause | Trial comparisons |
| Pasireotide LAR (SOM230) vs Placebo Injection: serious adverse events | Trial comparisons |
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/NCT01670110
GET https://conductscience.org/api/trials/v1/NCT01670110/results?page=2