Chronic Hepatitis C Clinical Trial
— SASAOfficial title:
An Observational Study Exploring the Utility of the Sysmex-XN 20 Analyser to Assess Lymphocyte Subsets and Other Haematological Parameters in Chronic or Acute Viral Infections,
The XN-20, is a full blood count (FBC) analyser with an extended differential counting and
flagging System. The XN-Series' individual channels allow real-time reflex analysis, and uses
a two stage process to classify the white blood count (WBC) sub-populations and detect the
presence of abnormal reactive and malignant cells. In regards to lymphocytes in the
peripheral blood, the machine has the capacity to distinguish activated from non-activated
T-cell subsets using a very small volume of EDTA sample (88uL) (including remnant sample from
a standard full blood count) with results available in 1.5 minutes. It is a fully automated
process and can be considered as an alternative rapid flow cytometry method.
Objective of the SASA study: to investigate the signal pattern of white blood cells assessed
using the XN-20 full blood count platform in patients with untreated viral infections i.e.
HIV, HCV and HBV. The data from the analysis will be reviewed in conjunction with patient's
demographic and clinical disease characteristics with the aim of detecting characteristic
cell populations that can be used in the development of system flags for future studies.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | October 15, 2018 |
Est. primary completion date | August 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adults aged =18 years; - Registered patient at Mortimer Market Centre; - Willing to have a blood draw for the purpose of the study or, if the participant is having a blood draw for routine care, willing to have an additional EDTA sample taken at the time of that routine blood draw and willing that the results of the sample being drawn for standard care (FBC and T-cell subsets) can be used for this study; In one of the four mutually exclusive groups: i) Group A: HIV-infected (chronic or acute infection) with a HIV viral load of >1000 copies/mL in the 6 months prior to study entry and not (yet) in receipt of combination antiretroviral therapy (cART) at study entry; ii) Group B: HIV-infected on cART with HIV viral load <50 copies/mL within the 6 months prior to study entry, at least one measure of HCV (chronic or acute infection) showing a detectable HCV viral load and not in receipt of HCV treatment at study entry; iii) Group C: HCV mono-infected (chronic or acute infection) with detectable HCV viral load (>lower limit of quantification) in the prior 6 months and not in receipt of HCV treatment at study entry; iv) Group D: HBV mono-infected (chronic or acute infection) patients with detectable HBV viral load in the prior 6 months and not in receipt of HBV treatment at study entry. - written informed consent. Exclusion Criteria: - On immunosuppressants and/or receiving chemotherapy or radiotherapy for a malignancy; - Intercurrent infection within the prior 30 days (e.g. influenza like illness). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Mortimer Market centre | London |
Lead Sponsor | Collaborator |
---|---|
University College, London | Central and North West London NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of lymphocytes measured in area D1+D2 of the XN WDF and W1/W2 ratio from the WPC channel. | Day 1 | ||
Secondary | % lymphocytes in the D1 and D2 area of the XN WDF channel | as above | Day 1 | |
Secondary | % lymphocytes in the D0 area of the XN WDF channel; | as above | Day 1 | |
Secondary | correlation between CD4+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel; | as above | Day 1 | |
Secondary | correlation between CD8+ T-cells (as measured by standard flow cytometry) and the D1+D2 area on the XN WDF channel; | as above | Day 1 | |
Secondary | correlation between CD4+ T-cells (as measured by standard flow cytometry) and the W1/W2 area on the XN WPC channel; | as above | Day 1 | |
Secondary | correlation between CD8+ T-cells (as measured by standard flow cytometry) and the W1/W2 area on the XN WPC channel; | as above | Day 1 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01937975 -
The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)
|
Phase 1 | |
Completed |
NCT03673696 -
The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects
|
Phase 1 | |
Completed |
NCT02250001 -
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
|
N/A | |
Completed |
NCT03088917 -
'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'
|
||
Completed |
NCT02207088 -
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
|
Phase 3 | |
Not yet recruiting |
NCT02865369 -
Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment
|
N/A | |
Recruiting |
NCT02638233 -
Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy
|
Phase 4 | |
Not yet recruiting |
NCT02511496 -
Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia
|
N/A | |
Completed |
NCT02788682 -
Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy
|
N/A | |
Not yet recruiting |
NCT01949168 -
A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV
|
Phase 2 | |
Completed |
NCT01439776 -
Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients
|
Phase 4 | |
Recruiting |
NCT01360879 -
Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease
|
N/A | |
Recruiting |
NCT01360892 -
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography
|
N/A | |
Completed |
NCT00968357 -
Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed
|
Phase 2 | |
Terminated |
NCT00962936 -
Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection
|
Phase 1/Phase 2 | |
Recruiting |
NCT01178749 -
Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments
|
N/A | |
Recruiting |
NCT00575627 -
Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels
|
Phase 4 | |
Completed |
NCT00537407 -
A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment
|
Phase 2 | |
Recruiting |
NCT00370617 -
Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance
|
Phase 4 | |
Completed |
NCT01684787 -
Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients
|
Phase 4 |