Trial · NCT05776940
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Occurrence of diarrhea | Up to 3 months after enrollment | Increased stool frequency and/or loose or watery stools |
| Secondary | Time before diarrhea | Up to 3 months after enrollment | Time interval from the start of treatment to the first diarrhea |
| Secondary | Duration of the diarrhea | Up to 6 months after enrollment | The time between the start of diarrhea and the last diarrhea. |
| Secondary | Hematological response at 3 and 6 months after enrollment | Up to 6 months after enrollment | Hematological response is evaluated according to the difference between Serum free light chains and immunofixation electrophoresis. |
| Secondary | Involved organ response（heart）at 3 and 6 months after enrollment | Up to 6 months after enrollment | Involved organ response（heart）is evaluated according to the change of NT-proBNP. |
| Secondary | SF-36 score at 1 month, 3 month and 6 month | Up to 6 months after enrollment | The general health condition is evaluated by the 36-item Short-Form. The SF-36 measure consists of 36 items that address the following 8 dimensions: physical pain, mental health, general health, emotional role functioning, social functioning, vitality, and physical and role functioning. Each dimension receives a final score between 0 and 100, with 100 representing the best performance. |
| Secondary | GSRS score at 1 month, 3 month and 6 month | Up to 6 months after enrollment | The Gastrointestinal Symptoms are evaluated by Gastrointestinal Symptom Rating Scale. The minimum and maximum values is 15 and 105, respectively. The scores are calculated by taking the mean of the items completed within an individual scale, with higher scores indicating greater severity of symptoms. |
| Secondary | Other adverse events that occurred during the treatment | Up to 6 months after enrollment | Adverse events are evaluated according to the CTCAE 5.0. |
| Secondary | Survival status at study endpoints | From date of randomization until the date of death from any cause, assessed up to 36 months | Survival status（live or dead） |
| Secondary | Changes of al amyloidosis patients' gut microbiome at 3 months and 6 months after enrollment | Up to 6 months after enrollment. | The changes of gut microbiome are evaluated by 16sRNA (such as Microbiota α-diversity and β-diversity、Changes in gut microbiota at the phylum and the genus levels、Phylogenetic profiles of the gut microbial communities、Microbial functional alteration、Correlations between significantly different ASVs and clinical characteristics in AL amyloidosis patients.etc.) |
| Secondary | Severity of the diarrhea | Up to 6 months after enrollment | The severity of diarrhea was graded according to the CTCAE 5.0. |
| Secondary | Involved organ response（kidney）at 3 and 6 months after enrollment | Up to 6 months after enrollment | Involved organ response（kidney）is evaluated according to the change of 24h proteinuria. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05776940/registered