Trial · NCT06733519
TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis
NCT06733519, Phase 2, Not yet recruiting, Tharimmune Inc
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis. Trials, record NCT06733519. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06733519
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis
- NCT number
- NCT06733519
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Tharimmune Inc
- Conditions
- Pruritus, Primary Biliary Cholangitis
- Interventions
- Nalmefene, Placebo
- First posted
- 2024-12-13
- Last updated
- 2025-09-09
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary objective is to investigate the safety and tolerability of repeat doses of TH104 | 42 days | Percentage of participants with treatment-related adverse events as coded by MedDRA. |
| Secondary | Difference in daily itch score between TH104 and placebo | 42 days | |
| Secondary | Change in participants reported outcome for PBC-40 questionnaire | 42 days | The PBC-40 is a disease specific questionnaire that assess PBC related symptoms . The six domains of PBC-40 relate to fatigue, emotional, social, and cognitive function, general symptoms, and itch |
| Secondary | Change in participants reported outcome for 5-D itch questionnaire. | 42 days | The 5-D itch scale was developed as a brief but multidimensional questionnaire designed to be useful as an outcome measure in clinical trials. The five dimensions are degree, duration, direction, disability and distribution. |
| Secondary | Change in participants reported outcome for EQ5D quality of life questionnaire | 42 days | EQ-5D assesses health status in terms of five dimensions of health. |
| Secondary | Change in Fatigue Severity Scale from baseline to the end of treatment. | 42 days | The FSS questionnaire contains nine statements that rate the severity of fatigue symptoms |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT06733519
GET https://conductscience.org/api/trials/v1/NCT06733519/registered