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NCT02528461
Measuring Inflammation Cells (CD163 and CD206) With the Purpose of Examining Reduction of Fibrosis in the Liver of Chronic Hepatitis C Patients Following Treatment With the Medication Sofosbuvir
trial testing Galactose in Hepatitis C in 71 participants. Completed in 1 January 2020.
1 January 2019
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 71 |
| Start date | 1 January 2015 |
| Primary completion | 1 January 2019 |
| Estimated completion | 1 January 2020 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Galactose (GALACTOSE) — full drug profile →
- Gastroscopy
- Liver biopsy — full drug profile →
- Fibroscan
- Liver vein catheterization
- Sofosbuvir — full drug profile →
Conditions studied
- Hepatitis C — all drugs for Hepatitis C →
Sponsor
University of Aarhus
Who can join
Adults 18 to 75, any sex, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Changes in the macrophage activation markers sCD163 and sCD206
Time frame: 1 year
Sponsor's own description
The purpose of the study is to investigate how the liver is affected with regard to inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C. In order to examine how the liver heals, we want to use blood samples to check for the occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of ultrasound examination) and also preferably with extraction of a small tissue sample. We want to examine how the liver function as inflammation and scar tissue decrease, especially concerning the liver's ability to produce proteins. Furthermore, we want to examine with a gastroscopy, if the circulation of blood in the liver is improved after successful treatment with the expected result that potential varicose veins in the esophagus vanish.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
The role of macrophage subtypes and exosomes in immunomodulation.
Gharavi AT, Hanjani NA, Movahed E, Doroudian M. · · 2022 · cited 146× · PMID 36192691 · DOI 10.1186/s11658-022-00384-y
Verify or expand the search:
- PubMed search for NCT02528461
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Hepatitis C
Currently open trials in the same condition.
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- NCT05668780 — Buprenorphine Integration Research and Community Health · NA · active not recruiting
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Other University of Aarhus trials
Trials by the same sponsor.
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- NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
- NCT07528339 — Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK) · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02528461 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
- Last refreshed: 6 April 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02528461.
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