| 1 |
NCT02799355 |
Completed |
Treatment of Chronic Hepatitis With Sofosbuvir in Combination With Ribavirin With or Without Pegylated Interferon: North India Gastroenterology Consortium |
|
- Drug: Sofosbuvir, Ribavirin, With or Without Pegylated Interferon
|
Observational |
|
- Dayanand Medical College and Hospital
|
Other |
- Time Perspective: Retrospective
|
- Proportion of patients with sustained virologic response at 12 weeks after the end of treatment.
- Side effect
|
1203 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02799355 |
GCNI-CHC |
GCNI-CHC |
May 2016 |
September 2016 |
September 2016 |
June 14, 2016 |
September 27, 2016 |
|
- Department of Gastroenterology, D.M.C. and Hospital
Ludhiana, Punjab, India
|
| 2 |
NCT01980290 |
Completed |
Telaprevir With Peginterferon Alfa & Ribavirin in Ex-People Who INject Drugs Infected by Genotype 1 Chronic Hepatitis C |
|
|
Observational |
|
- Janssen Pharmaceutica N.V., Belgium
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Sustained Virologic Response at 12 weeks (SVR12)
- adherence to telaprevir until Week 12
- adherence to PegIFN alfa and RBV
- (and 5 more...)
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT01980290 |
CR100966
VX-950HPC4017 |
INTEGRATE |
May 2013 |
February 2015 |
February 2015 |
November 8, 2013 |
March 3, 2017 |
|
- Antwerpen, Belgium
- Brussels, Belgium
- Bruxelles, Belgium
- (and 16 more...)
|
| 3 |
NCT01005238 |
Terminated |
Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine |
|
- Drug: Lamivudine
- Drug: Telbivudine
|
Interventional |
Phase 4 |
- University Hospital, Basel, Switzerland
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary endpoint is the rate of viral breakthrough during treatment defined as an increase of the viral titer to > 200 IU/mL.
|
27 |
All |
18 Years and older (Adult, Senior) |
NCT01005238 |
SASL28 |
SASL28 |
September 2009 |
December 2014 |
|
October 30, 2009 |
March 10, 2015 |
|
- University Hospital
Basel, Switzerland
|
| 4 |
NCT02893124 |
Active, not recruiting |
The Optimizing Treatment of Peginterferon (PEG IFN) Alpha in Chronic Hepatitis B Virus Patients With Low Level HBsAg |
|
|
Interventional |
Phase 4 |
- Third Affiliated Hospital, Sun Yat-Sen University
- Peking University
- Huazhong University of Science and Technology
- (and 8 more...)
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- HBsAg Clearance
- HBsAg Seroconversion
|
200 |
All |
18 Years to 65 Years (Adult) |
NCT02893124 |
I-Cure-3 |
|
August 2016 |
August 2017 |
|
September 8, 2016 |
September 8, 2016 |
|
- Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
|
| 5 |
NCT02965859 |
Recruiting |
The Safety and Dose-range Study of Metacavir Enteric-coated Capsules in Patients With Chronic Hepatitis B |
|
- Drug: Metacavir Enteric-coated Capsules 80mg
- Drug: Metacavir Enteric-coated Capsules 160mg
- Drug: Metacavir Enteric-coated Capsules 320mg
- (and 5 more...)
|
Interventional |
Phase 2 |
- Guangzhou Yipinhong Pharmaceutical CO.,LTD
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.
- Incidence of treatment-chronic hepatitis B
- Incidence of Adverse Events(AEs)
|
180 |
All |
18 Years to 65 Years (Adult) |
NCT02965859 |
PNA-20140110-v2 |
|
December 2012 |
December 2018 |
|
November 17, 2016 |
November 22, 2016 |
|
- 81 Military Hospital of China
Nanjing, Jiangsu, China
|
| 6 |
NCT02006823 |
Completed |
Patient Self-management and Gene Guided Therapy for Chronic Hepatitis C |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in Self Management
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT02006823 |
Pro00035949 |
|
March 2012 |
July 2014 |
July 2014 |
December 10, 2013 |
December 15, 2014 |
|
- Duke University Medical Center
Durham, North Carolina, United States - Boice Willis Clinic
Rocky Mount, North Carolina, United States
|
| 7 |
NCT02883647 |
Recruiting |
Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis b |
|
- Drug: Entecavir or Tenofovir
|
Observational |
|
- Third Affiliated Hospital, Sun Yat-Sen University
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- relapse
- occurence of cirrhosis and hepatocellular carcinoma
|
100 |
All |
18 Years to 65 Years (Adult) |
NCT02883647 |
PL |
|
January 2014 |
December 2017 |
December 2017 |
August 30, 2016 |
August 30, 2016 |
|
- The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
|
| 8 |
NCT02364336 |
Recruiting |
Mechanisms Associated With Favorable Responses to Peginterferon-Alpha Add-on Therapy Following Long-term Nucleos(t)Ide Analogue Treatment in Patients With Chronic Hepatitis B |
|
- Drug: Peginterferon alfa-2a
|
Interventional |
Phase 2 |
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in interferon-stimulated-genes
- HBeAg and HBsAg seroconversion
|
60 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT02364336 |
150082
15-DK-0082 |
|
February 14, 2015 |
September 30, 2018 |
September 30, 2018 |
February 18, 2015 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 9 |
NCT01911156 |
Unknown † |
Sustained Off-treatment Response After HBeAg Loss in Chronic Hepatitis B Patients Treated With Nucleos(t)Ide Analogues |
|
- Drug: Continue NA treatment
- Drug: Discontinue NA Treatment
|
Interventional |
Phase 4 |
- University Health Network, Toronto
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Sustained response, defined as the presence of an HBV DNA level <2000 IU/ml at week 48 in patients with a combined response at baseline
|
66 |
All |
18 Years and older (Adult, Senior) |
NCT01911156 |
Stop Study
GILEAD Sciences Canada, Inc. |
Stop |
July 2013 |
January 2016 |
March 2016 |
July 30, 2013 |
May 28, 2015 |
|
- University Health Network
Toronto, Ontario, Canada - University Health Network
Toronto, Ontario, Canada
|
| 10 |
NCT02216045 |
Completed |
Effect of Camel Milk on Chronic Hepatitis C |
|
- Drug: Peginterferon, Ribavirin, camel milk
- Drug: Peginterferon, Ribavirin
|
Interventional |
Phase 2 |
- Mashhad University of Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Early Virologic Responses(EVR)
- Complete early virological response (cEVR)
- o Complete early virological response (cEVR)
- (and 4 more...)
|
40 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02216045 |
Mashhad UMS |
HCV |
June 2014 |
February 2015 |
February 2015 |
August 13, 2014 |
July 29, 2016 |
|
- Faculty of Traditional Medicine
Mashhad, Khorasan-e-Razavi, Iran, Islamic Republic of - Mashhad University of Medical Sciences
Mashhad, Khorasan-e-Razavi, Iran, Islamic Republic of
|
| 11 |
NCT02662712 |
Recruiting |
A Study of Orally Administered JNJ-56136379 to Evaluate Safety, Tolerability and Pharmacokinetics After Single Ascending Doses and One Multiple Dose Regimen in Healthy Participants (Part I), and After Multiple Dose Regimens in Participants With Chronic Hepatitis B (Part II) |
- Healthy
- Hepatitis, Chronic
|
- Drug: JNJ-56136379
- Drug: Placebo
|
Interventional |
Phase 1 |
- Janssen Sciences Ireland UC
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Other
|
- Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
- Part 2: Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events
- Part 1 Single Ascending Dose and Multiple Dose : Number of Participants With Abnormal Physical Examinations
- (and 17 more...)
|
84 |
All |
18 Years to 65 Years (Adult) |
NCT02662712 |
CR108092
56136379HPB1001
2015-003724-30 |
|
December 2015 |
May 2018 |
August 2018 |
January 25, 2016 |
March 29, 2018 |
|
- Cliniques Universitaires Saint-Luc
Brussel, Belgium - UZ Antwerpen
Edegem, Belgium - Az Sint-Maarten
Mechelen, Belgium - (and 26 more...)
|
| 12 |
NCT00418639 |
Completed |
Study of Nitazoxanide in the Treatment of Chronic Hepatitis C |
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Virologic response
- Sustained virologic response
- Quantitative serum HCV RNA
- Changes in ALT
|
50 |
All |
18 Years and older (Adult, Senior) |
NCT00418639 |
RM01-3027 |
|
February 2005 |
|
|
January 5, 2007 |
January 5, 2007 |
|
- Department of Tropical Medicine & Infectious Diseases, Alexandria University
Alexandria, Egypt - Cairo Liver & GIT Center
Cairo, Egypt - Department of Tropical Medicine & Infectious Diseases, Tanta University School of Medicine
Tanta, Egypt
|
| 13 |
NCT00645736 |
Completed |
CHARM: Chronic Hepatitis B Antihepadnaviral Resistance Mutation Study |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Descriptive statistics for clinical and viral characteristics of the study population
|
788 |
All |
18 Years and older (Adult, Senior) |
NCT00645736 |
GS-AU-103-0185 |
CHARM |
February 2008 |
October 2008 |
November 2008 |
March 28, 2008 |
November 22, 2011 |
|
- Gilead Sciences Pty Ltd
East Melbourne, Victoria, Australia
|
| 14 |
NCT01342185 |
Unknown † |
Efficacy of Medical Ozone Therapy in Patients With Chronic Hepatitis B |
|
- Device: medical ozone therapy with tianyi
- Device: medical ozone therapy with humares
- Drug: Diammonium glycyrrhizinate Capsules
|
Interventional |
Phase 3 |
- Nanfang Hospital of Southern Medical University
- Tianyi medical instruments limited company, Ningbo, China
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
189 |
All |
16 Years and older (Child, Adult, Senior) |
NCT01342185 |
a4xr2dv8 |
EMOTCHB |
March 2010 |
July 2013 |
July 2013 |
April 27, 2011 |
October 18, 2012 |
|
- Nanfang Hospital
GuangZhou, Guangdong, China
|
| 15 |
NCT00828269 |
Completed |
Evaluation of RNA From the Liver Tissue Obtained in Patients With Chronic Hepatitis C (0000-123) |
|
- Procedure: Comparator: Fine needle aspiration biopsy
|
Interventional |
Phase 1 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Participant)
- Primary Purpose: Diagnostic
|
- To evaluate the probability that fine needle aspiration of the liver results in RNA suitable to conduct gene expression tests.
- Comparison of qPCR and microarray signature from patients with no or minimal fibrosis to that from patients with moderate to advanced fibrosis.
|
12 |
All |
18 Years to 65 Years (Adult) |
NCT00828269 |
0000-123
123
2009_518 |
|
April 2009 |
February 2010 |
March 2010 |
January 23, 2009 |
April 22, 2015 |
|
|
| 16 |
NCT01373684 |
Recruiting |
PEG-interferon Alfa-2a add-on Study in HBeAg Negative Chronic Hepatitis B Patients |
|
- Drug: Peginterferon alfa-2a
- Drug: Nucleos(t)ide analogue
|
Interventional |
Phase 4 |
- Foundation for Liver Research
- Hoffmann-La Roche
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
90 |
All |
18 Years and older (Adult, Senior) |
NCT01373684 |
HBV11-01 |
PAS |
March 2012 |
June 2019 |
October 2019 |
June 15, 2011 |
December 21, 2017 |
|
- Western Hospital
Toronto, Canada - Erasmus Medical Center
Rotterdam, Zuid Holland, Netherlands - Medisch Centrum Alkmaar
Alkmaar, Netherlands - (and 11 more...)
|
| 17 |
NCT02058108 |
Active, not recruiting |
Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection |
|
- Drug: Telbivudine
- Drug: Placebo
|
Interventional |
Phase 3 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Antiviral efficacy of telbivudine compared to placebo in pediatric patients (2- < 18 years) (percentage of patients achieving serum HBV DNA level of <300 copies/mL (51 IU/mL)) at Week 24
- Antiviral efficacy (proportion of patients achieving HBV DNA< 300 copies/mL (51 IU/mL)) at Week 52 and Week 104
- Biochemical response (proportion of patients whose baseline ALTs were abnormal and subsequently normalized) at Week 24, 52 and 104
- (and 5 more...)
|
53 |
All |
2 Years to 17 Years (Child) |
NCT02058108 |
CLDT600A2306 |
|
October 31, 2014 |
December 27, 2019 |
December 27, 2019 |
February 7, 2014 |
August 3, 2017 |
|
- Novartis Investigative Site
Sofia, Sofia-Grad, Bulgaria - Novartis Investigative Site
Pleven, Bulgaria - Novartis Investigative Site
Sofia, Bulgaria - (and 26 more...)
|
| 18 |
NCT00876174 |
Terminated |
Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C |
|
- Procedure: Blood sampling of peripheral blood mononuclear cells
- Procedure: Blood draw, 20ml peripheral blood mononuclear cells
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- To investigate the prognostic criteria for sensitivity of Chronic Hepatitis C patients to interferon alpha treatment
- To determine the effects of antiviral treatment on interferon gene signaling in peripheral blood mononuclear cells
|
30 |
All |
19 Years and older (Adult, Senior) |
NCT00876174 |
143-09-EP |
|
May 2009 |
|
January 2010 |
April 6, 2009 |
January 12, 2010 |
|
- University of Nebraska Medical Center
Omaha, Nebraska, United States
|
| 19 |
NCT00209755 |
Terminated |
Plasma Ribavirin Assay During Combination Therapy for Chronic Hepatitis C |
|
- Procedure: therapeutic drug monitoring of ribavirin and dose adaptation
|
Interventional |
Not Applicable |
- Hopital A Michallon
- University Hospital, Grenoble
- Central Hospital, Nancy, France
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- relationship between plasma ribavirin concentration and early virological response
- safety
- relationship between plasma ribavirin concentration and hemoglobin drop
- dose effect of ribavirin on ribavirin plasma concentration
|
40 |
All |
18 Years to 65 Years (Adult) |
NCT00209755 |
ribatop - afssaps #031161
N.A. |
|
October 2003 |
|
July 2004 |
September 21, 2005 |
September 21, 2005 |
|
- university hospital ; HGE dpt
Grenoble, France
|
| 20 |
NCT00724776 |
Completed |
Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients |
|
- Biological: Albinterferon alfa 2b
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and tolerability after single dose
- Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation
|
30 |
All |
20 Years to 69 Years (Adult, Senior) |
NCT00724776 |
CABF656A1202 |
|
July 2008 |
July 2009 |
|
July 30, 2008 |
August 11, 2010 |
|
- Novartis Pharmaceuticals, Japan
Tokyo, Japan
|
| 21 |
NCT03429439 |
Recruiting |
Study on Effect of Intestinal Microbiota Transplantation in Chronic Hepatitis B |
|
- Other: intestinal microbiota transplant
- Drug: Antiviral Agents
|
Interventional |
Not Applicable |
- Zhongshan Hospital Xiamen University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change of serum hepatitis B virus e antigen(HBeAg) level
- Change of serum hepatitis B virus surface antigen(HBsAg) level
- Change of serum anti-hepatitis B virus e antigen(anti-HBe)
- (and 5 more...)
|
60 |
All |
18 Years to 65 Years (Adult) |
NCT03429439 |
2017003 |
CHB |
December 29, 2017 |
October 2020 |
November 2020 |
February 12, 2018 |
February 12, 2018 |
|
- Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
|
| 22 |
NCT03481036 |
Recruiting
New |
DAA Therapy in Pediatric Patients With Chronic Hepatitis C |
|
- Drug: Direct Acting Antivirals
|
Interventional |
Not Applicable |
- Postgraduate Institute of Medical Education and Research
- Directorate of Health and Family Welfare, Punjab
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Sustained Virological Response (SVR 12)
|
100 |
All |
12 Years to 18 Years (Child, Adult) |
NCT03481036 |
IEC/2018/000323 |
|
June 18, 2016 |
December 31, 2020 |
December 31, 2020 |
March 29, 2018 |
March 29, 2018 |
|
- Post Graduate Institute of Medical Education and Research
Chandigarh, India
|
| 23 |
NCT00200343 |
Completed
Has Results |
Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C |
|
- Drug: Ursodeoxycholic acid 150mg / day
- Drug: Ursodeoxycholic acid 600mg / day
- Drug: Ursodeoxycholic acid 900mg / day
|
Interventional |
Phase 3 |
- Mitsubishi Tanabe Pharma Corporation
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Alanine Aminotransferase at Baseline
- Percentage Change of Alanine Aminotransferase From Baseline at Week 24
- Aspartate Aminotransferase at Baseline
- (and 3 more...)
|
596 |
All |
20 Years and older (Adult, Senior) |
NCT00200343 |
MT711-01 |
|
July 2002 |
|
December 2004 |
September 20, 2005 |
March 12, 2012 |
November 7, 2011 |
- Department of Gastroenterology, University of Tokyo
hongo, bunkyo-ku, Tokyo, Japan
|
| 24 |
NCT02452528 |
Terminated
Has Results |
Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus |
|
- Drug: ARC-520
- Drug: Placebo
- Drug: Entecavir
- (and 2 more...)
|
Interventional |
Phase 2 |
- Arrowhead Pharmaceuticals
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)
- Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
- (and 11 more...)
|
4 |
All |
18 Years to 75 Years (Adult, Senior) |
NCT02452528 |
Heparc-2004 |
|
August 2015 |
December 2016 |
December 2016 |
May 22, 2015 |
December 5, 2017 |
November 1, 2017 |
- Kaiser Permanente
San Francisco, California, United States - Univ. Of Miami School Of Medicine/Center For Liver Diseases
Miami, Florida, United States - Ichan School of Medicine at Mount Sinai
New York, New York, United States - The Texas Liver Institute
San Antonio, Texas, United States
|
| 25 |
NCT00763568 |
Completed |
4-Week Lead-In With Nitazoxanide Followed by 36 Weeks Nitazoxanide and Peginterferon Alfa-2a in Chronic Hepatitis C |
|
- Drug: Nitazoxanide
- Biological: Peginterferon alfa-2a
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Sustained virologic response
- End of treatment virologic response
- Early virologic response
- (and 2 more...)
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT00763568 |
RM01-3037 |
|
August 2006 |
September 2008 |
September 2008 |
October 1, 2008 |
October 1, 2008 |
|
- Digestive Disease Center
Tanta, Egypt
|
| 26 |
NCT02862106 |
Completed
Has Results |
Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B |
|
|
Interventional |
Phase 2 |
- Chongqing Jiachen Biotechnology Ltd.
- Third Military Medical University
|
Industry / Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period
- The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144
- The Proportion of Patients With Both Negative HBeAg and HBeAb.
- (and 6 more...)
|
209 |
All |
18 Years to 65 Years (Adult) |
NCT02862106 |
71006.01-2 |
|
September 2010 |
March 2013 |
March 2013 |
August 10, 2016 |
March 31, 2017 |
January 18, 2017 |
- Renmin Hosptial of Wuhan University
WuHan, Hubei, China - The Second Xiangya Hospital of Central South University
Changsha, Hunan, China - Xiangya Hospital Central South University
ChangSha, Hunan, China - (and 6 more...)
|
| 27 |
NCT00291616 |
Completed |
Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B |
|
- Drug: Pegylated Interferon-alpha2a
- Drug: Thymosin alpha1 & Pegylated Interferon-alpha2a
|
Interventional |
Phase 4 |
- Seoul National University Hospital
- Roche Pharma AG
- SciClone Pharmaceuticals
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- HBeAg seroconversion, HBV DNA titer<20,000 IU/mL
- Normalization of serum ALT, loss of HBeAg and HBsAg, production of anti-HBs
|
52 |
All |
18 Years and older (Adult, Senior) |
NCT00291616 |
12-05-008 |
|
December 2005 |
August 2008 |
August 2008 |
February 14, 2006 |
July 21, 2011 |
|
- Seoul National University Hospital
Seoul, Chongno-gu, Korea, Republic of
|
| 28 |
NCT01760122 |
Completed |
Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B |
|
- Drug: Ypeginterferon alfa-2b
- Drug: Pegasys
|
Interventional |
Phase 3 |
- Xiamen Amoytop Biotech Co., Ltd.
- Peking University First Hospital
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients with HBeAg seroconversion at week72
- Proportion of Patients with HBeAg seroconversion at week 12,24,48
- Proportion fo patients with HBeAg undetectable at week 12, 24, 48, and 72.
- (and 3 more...)
|
820 |
All |
18 Years to 65 Years (Adult) |
NCT01760122 |
TB1211IFN |
|
March 2013 |
July 2015 |
August 2015 |
January 3, 2013 |
August 31, 2015 |
|
- Xiamen Hospital of T.C.M
Xiamen, Fujian, China - Beijing University Shenzhen Hospital
Shenzhen, Guangdong, China - 302 Military Hospital
Beijing, China - (and 40 more...)
|
| 29 |
NCT01655966 |
Unknown † |
Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c |
|
- Drug: vitamin D +pegylated interferon + ribavirin
- Drug: pegylated interferon + ribavirin
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Sustained virologic response
- rapid virologic response
- End-of-treatment response
- (and 2 more...)
|
80 |
All |
18 Years to 65 Years (Adult) |
NCT01655966 |
RAIL002 |
|
May 2012 |
February 2014 |
April 2014 |
August 2, 2012 |
January 29, 2014 |
|
- National Railway Hospital Center
Cairo, Egypt
|
| 30 |
NCT02973646 |
Recruiting |
Peginterferon Alfa-2b Treatment in HBeAg(+) Chronic Hepatitis b Patients Based on Interferon Gene Mutation and Receptor Detection |
|
- Drug: Entecavir or Tenofovir
- Drug: Peginterferon Alfa-2B
|
Interventional |
Phase 4 |
- Third Affiliated Hospital, Sun Yat-Sen University
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- good virologic response
- common virologic response
- bad virologic response
|
100 |
All |
18 Years to 65 Years (Adult) |
NCT02973646 |
PL2 |
|
January 2016 |
December 2018 |
December 2018 |
November 25, 2016 |
November 25, 2016 |
|
- The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
|
| 31 |
NCT01726946 |
Completed |
A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C |
|
- Drug: VX-135
- Drug: ribavirin
|
Interventional |
Phase 2 |
- Vertex Pharmaceuticals Incorporated
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments
- The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)
- The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
- (and 6 more...)
|
10 |
All |
18 Years to 60 Years (Adult) |
NCT01726946 |
VX12-135-101 |
|
November 2012 |
February 2014 |
February 2014 |
November 15, 2012 |
April 16, 2015 |
|
- California
La Jolla, California, United States - Florida
Orlando, Florida, United States - Georgia
Marietta, Georgia, United States - (and 3 more...)
|
| 32 |
NCT00715715 |
Withdrawn |
Efficacy Study of Prednisone Priming to Treat Asian Chronic Hepatitis B Patients |
|
|
Interventional |
Not Applicable |
- Maimonides Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- The primary efficacy end points at week 48 include the reduction in HBV DNA, HBeAg seroconversion, normalization of ALT.
- Secondary efficacy end point is the proportion of patients with histologic improvement.
|
0 |
All |
16 Years and older (Child, Adult, Senior) |
NCT00715715 |
08-01-IVA6 |
|
April 2008 |
February 2011 |
February 2011 |
July 15, 2008 |
April 20, 2012 |
|
- Maimonides Medical Center
Brooklyn, New York, United States
|
| 33 |
NCT01769833 |
Unknown † |
HBsAg Decline After Pegylated-interferon-α in e Antigen Positive Chronic Hepatitis B With Nucleoside Maintenance |
|
- Drug: PEG-interferon-Alfa-2A
- Drug: Nucleosides
|
Interventional |
Phase 3 |
- Pusan National University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in log10 HBsAg titer during antiviral therapy
- HBV DNA undetectability and below 400 IU/mL during antiviral therapy and follow-up
- HBeAg seroconversion and loss during antiviral therapy and at end of treatment and 1 and 2 years following end of treatment
- (and 3 more...)
|
144 |
All |
18 Years and older (Adult, Senior) |
NCT01769833 |
ML25659 |
|
May 2013 |
May 2015 |
May 2016 |
January 17, 2013 |
November 4, 2014 |
|
- Pusan National University Hospital
Busan, Korea, Republic of
|
| 34 |
NCT01684787 |
Completed |
Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients |
|
- Drug: Peginterferon alfa-2a + ribavirin in normal ALT
- Drug: Peginterferon alfa-2a + ribavirin in elevated ALT
|
Interventional |
Phase 4 |
- Miguel Santin
- Hospital Universitari de Bellvitge
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- % patients with RNA-HCV negative
|
80 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT01684787 |
Miguel Santín |
CONTRA |
September 2006 |
May 2011 |
June 2011 |
September 13, 2012 |
September 13, 2012 |
|
- Hospital de Txagorritxu
Vitoria, Alava, Spain - Consorci Sanitari Integral
Hospitalet, Barcelona, Spain - Hospital Universitari of Bellvitge
Hospitalet, Barcelona, Spain - (and 15 more...)
|
| 35 |
NCT02387684 |
Recruiting |
Efficay of Extended Peginterferon Alpha 2a Treatment in HBeAg Negative Chronic Hepatitis B Patients |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- rate of sustained viral response
- rate of HBsAg loss
|
120 |
All |
18 Years to 60 Years (Adult) |
NCT02387684 |
DTXY007 |
|
April 2012 |
December 2016 |
December 2016 |
March 13, 2015 |
August 19, 2016 |
|
- Beijing Ditan hospital,Capital Medical University
Beijing, Beijing, China
|
| 36 |
NCT01531166 |
Completed |
A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon |
|
- Drug: pegylated Interferon-alpha 2a
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- HBsAg loss or appearance of anti-HBs antibody in treatment-naïve Korean CHB patients treated with Pegasys
- Sustained suppression of HBV DNA
- HBeAg loss and seroconversion in HBeAg-positive CHB
- ALT normalization
|
500 |
All |
20 Years to 65 Years (Adult) |
NCT01531166 |
4-2011-0461 |
|
September 2011 |
August 2014 |
October 2014 |
February 10, 2012 |
August 17, 2016 |
|
- Sang Hoon Ahn
Seoul, Seodaemun-gu, Korea, Republic of
|
| 37 |
NCT03357822 |
Not yet recruiting |
A Real-World Study of Pegylated Interferon In Nucleoside-treated Patients With Chronic Hepatitis B |
|
- Drug: Pegylated interferon
- Drug: Entecavir
- Drug: Tenofovir disoproxil fumarate
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- HBsAg loss rate
- HBsAg level
- sustained HBsAg loss rate
- (and 9 more...)
|
2000 |
All |
18 Years to 65 Years (Adult) |
NCT03357822 |
COST study |
COST |
January 1, 2018 |
October 1, 2020 |
October 1, 2021 |
November 30, 2017 |
November 30, 2017 |
|
- 302 Military Hospital of China
Beijing, Beijing, China - BeiJing YouAn Hospital, Capital Medical University
Beijing, Beijing, China - The First Hospital Affiliated to AMU
Chongqing, Chongqing, China - (and 9 more...)
|
| 38 |
NCT02362490 |
Recruiting |
Efficacy of Peginterferon Alpha 2a Therapy in Chronic Hepatitis B Patients Being Treated With Nucleoside(Acid) Analogues |
|
- Drug: peginterferon alpha 2a
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- rate of HBsAg loss
- decline of HBsAg level
|
200 |
All |
18 Years to 60 Years (Adult) |
NCT02362490 |
DTXY004 |
|
January 2013 |
December 2016 |
December 2016 |
February 13, 2015 |
September 13, 2016 |
|
- Beijing Ditan hospital,Capital Medical University
Beijing, Beijing, China
|
| 39 |
NCT02851069 |
Active, not recruiting |
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in Colombia |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
- The percentage of participants with virological response at end of treatment (EoT).
- The number of participants meeting premature study drug discontinuation
- (and 8 more...)
|
66 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02851069 |
P16-024 |
outCome |
February 27, 2017 |
June 30, 2018 |
June 30, 2018 |
August 1, 2016 |
January 17, 2018 |
|
- Fundacion Cardioinfantil
Bogota, Colombia - CIC CALI
Cali, Colombia - Centro Medico Imbanaco de Cali
Cali, Colombia - (and 3 more...)
|
| 40 |
NCT01522625 |
Active, not recruiting |
Tenofovir in Chronic Hepatitis B With Mild ALT Elevation |
|
- Drug: tenofovir disoproxil fumarate 300mg per day
- Drug: Placebo
|
Interventional |
Phase 4 |
- E-DA Hospital
- Gilead Sciences
- Taipei Institute of Pathology
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Care Provider)
- Primary Purpose: Treatment
|
- Severity of hepatic necroinflammation and fibrosis
- Undetectable hepatitis B viral DNA
- Normalization of serum alanine aminotransferase
- (and 2 more...)
|
160 |
All |
25 Years to 70 Years (Adult, Senior) |
NCT01522625 |
EMRP36100N |
|
January 2012 |
January 2018 |
December 2018 |
January 31, 2012 |
March 21, 2017 |
|
- Chia-Yi Christine Hospital
Chia-Yi, Taiwan - E-Da Hospital
Kaohsiung, Taiwan - Taichung Veterans General Hospital
Taichung, Taiwan - (and 3 more...)
|
| 41 |
NCT01326546 |
Unknown † |
Therapeutic Hepatitis B Vaccine (Synthesized Peptide εPA-44) Joint Entecavir in Treating Chronic Hepatitis B Patients |
|
- Drug: Therapeutic HBV vaccine, entecavir
- Drug: Empty liposome, entecavir
|
Interventional |
Phase 2 |
- Chongqing Jiachen Biotechnology Ltd.
- Third Military Medical University
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Primary efficacy assessment is the serological conversion rate of HBeAg at week. 48
- Serological response
- Virological response
- (and 2 more...)
|
378 |
All |
18 Years to 65 Years (Adult) |
NCT01326546 |
71006.04 |
THBVJEITCHBP |
June 2010 |
December 2012 |
March 2013 |
March 31, 2011 |
June 13, 2012 |
|
- Yida Yang
Hangzhou, Zhejiang, China
|
| 42 |
NCT01887275 |
Completed |
A Control Study to Evaluate The Efficacy And Safety of Ozone-therapy in Chronic Hepatitis B |
|
- Device: medical ozone therapy with humares
- Drug: conventional interferon-α
|
Interventional |
Phase 4 |
- Nanfang Hospital of Southern Medical University
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
439 |
All |
12 Years to 60 Years (Child, Adult) |
NCT01887275 |
gyb61641947 |
|
March 2010 |
February 2013 |
February 2013 |
June 26, 2013 |
June 26, 2013 |
|
- Nanfang Hospital
GuangZhou, Guangdong, China
|
| 43 |
NCT01189656 |
Unknown † |
A Clinical Study on Therapeutic Double-plasmid Hepatitis B Virus (HBV) DNA Vaccine in Patients With HBeAg-positive Chronic Hepatitis B |
- Chronic Hepatitis B Patients With HBeAg-positive
|
- Biological: HBV DNA Vaccine
|
Interventional |
Phase 2 |
- The 458 Hospital of Chinese PLA
- Guangzhou Baidi Biotechnology Co., Ltd
- Guangzhou Pharmaceucal Company Limited
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- The change of HBV DNA load at Week 72
- The rate of subjects with HBV DNA titer reducing > 2 logarithms .
- The change of HBeAg and HBsAg titer.
- (and 6 more...)
|
33 |
All |
18 Years to 65 Years (Adult) |
NCT01189656 |
71007.02 |
|
January 2009 |
November 2010 |
December 2010 |
August 27, 2010 |
August 27, 2010 |
|
- Department of Infections Disease of Peking University First Hospital
Beijing, Beijing, China
|
| 44 |
NCT02143180 |
Unknown † |
Accuracy of RTE for Evaluating Hepatic Fibrosis in Chronic Hepatitis: a Prospective Multicenter Study |
|
|
Observational |
|
- Third Affiliated Hospital, Sun Yat-Sen University
|
Other |
- Time Perspective: Prospective
|
- Liver Fibrosis Index (LFI)
|
500 |
All |
5 Years to 70 Years (Child, Adult, Senior) |
NCT02143180 |
ThirdSunYatSen |
|
May 2014 |
December 2015 |
|
May 20, 2014 |
May 20, 2014 |
|
- The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
Guangzhou, Guangdong, China
|
| 45 |
NCT00830609 |
Completed |
High Dose Versus Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3 |
|
- Drug: Peginterferon alfa 2 A
- Drug: Peginterferon alfa 2 A, ribavirin + Epo Beta
- Drug: ribavirin
- Drug: Peginterferon alfa 2
|
Interventional |
Phase 4 |
- Dr. Conrado Fernandez
- Hospital Universitario Fundación Alcorcón
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of patients with RNA-HCV negative in each arm at week 24 after the end of treatment.
- Rate of patients with undetectable RNA-HCV in each arm at week 4 and 24 of treatment. Rate of adverse effects in each arm.
|
101 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT00830609 |
ROCHE FARMA S.A. |
DARGEN-3 |
November 2008 |
September 2011 |
December 2011 |
January 28, 2009 |
March 13, 2012 |
|
- Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain - Hospital de Bellvitge
L´Hospitalet de Llobregat, Barcelona, Spain - Hospital Parc Taulí
Sabadell, Barcelona, Spain - (and 25 more...)
|
| 46 |
NCT02725866 |
Completed |
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
- The percentage of participants with virological response at end of treatment (EoT).
- The percentage of participants with relapse at EoT
- (and 5 more...)
|
216 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02725866 |
P15-842 |
|
April 5, 2016 |
October 20, 2017 |
October 20, 2017 |
April 1, 2016 |
October 24, 2017 |
|
- General University Hospital of Alexandroupolis /ID# 149494
Alexandroupolis, Greece - General University Hospital of Alexandroupolis /ID# 153776
Alexandroupolis, Greece - Evangelismos General Hospital of Athens /ID# 151259
Athens, Greece - (and 19 more...)
|
| 47 |
NCT02798315 |
Completed |
Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
- The percentage of the direct-acting antiviral (DAA) dose taken in relation to the target dose of DAA.
- The percentage of the Ribavirin (RBV) dose taken in relation to the target dose of RBV
- (and 8 more...)
|
40 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02798315 |
P15-699 |
|
May 25, 2016 |
June 12, 2017 |
June 12, 2017 |
June 14, 2016 |
June 21, 2017 |
|
- Adan Hospital /ID# 150776
Adan, Kuwait - Mubarak Hospital /ID# 150772
Hawalli, Kuwait - Mubarak Hospital /ID# 150773
Hawalli, Kuwait - (and 2 more...)
|
| 48 |
NCT02387463 |
Completed |
Efficacy of Extended Peginterferon Alpha 2a Treatment in HBeAg Positive Chronic Hepatitis B Patients |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- rate of HBeAg seroconversion (defined as HBeAg loss with anti-HBe positive after PEG-IFN a-2a treatment and follow up)
- rate of HBsAg loss (defined as HBsAg level lower than 0.05 IU/ml)
- rate of sustained viral response (defined as serum HBV DNA undetectable at the end of treatment and the end of follow up)
|
160 |
All |
18 Years to 60 Years (Adult) |
NCT02387463 |
DTXY008 |
|
March 2012 |
May 21, 2017 |
May 21, 2017 |
March 13, 2015 |
July 6, 2017 |
|
- Beijing Ditan hospital,Capital Medical University
Beijing, Beijing, China
|
| 49 |
NCT01533051 |
Unknown † |
Prospective Observational Cohort Study for the Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Sustained virological response after stopping anti-viral treatment
|
100 |
All |
20 Years to 75 Years (Adult, Senior) |
NCT01533051 |
Quit Anti-viral therapy |
|
February 2012 |
March 2015 |
March 2016 |
February 15, 2012 |
May 8, 2012 |
|
- Sang Hoon Ahn
Seoul, Korea, Republic of
|
| 50 |
NCT02817594 |
Active, not recruiting |
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C (3DUTCH) |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Percentage of participants achieving sustained virological response 12 weeks post-treatment (SVR12)
- The percentage of patients with virological response at end of treatment (EoT).
- The number of participants meeting premature study drug discontinuation
- (and 7 more...)
|
52 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT02817594 |
P15-788 |
3DUTCH |
January 25, 2016 |
September 1, 2018 |
September 1, 2018 |
June 29, 2016 |
February 5, 2018 |
|
- Noordwest Ziekenhuisgroep
Alkmaar, Netherlands - OLVG Locatie West
Amsterdam, Netherlands - Vrije Univ Medisch Centrum
Amsterdam, Netherlands - (and 9 more...)
|
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