Phase 2 N=13 Pegylated Interferon to Treat Chronic Hepatitis D
Hepatitis D
Primary: Histological Response at 3 Years — 6 participants
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Phase 2 N=14 Lonafarnib for Chronic Hepatitis D
Hepatitis D
Primary: Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy. — -0.13; -0.73; -1.54 log(IU/ml) — p=0.03
Phase 2 N=26 Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon
Liver Disease · Hepatitis D
Primary: Number of Participants With Decline of Hepatitis D Virus (HDV) RNA Viral Titer of >2 Logs — 18 Participants
Phase 2 N=21 Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir
Hepatitis D
Primary: Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment — 1; 1; 1; 0…
Phase 2 N=12 A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)
Hepatitis D, Chronic
Primary: Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment…
Phase 3 N=31 A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
Hepatitis D, Chronic
Primary: Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 — 54.84 percentage of participants
Phase 2 N=118 A Multicenter, Open-label, Randomized Clinical Study to Assess Efficacy and Safety of 3 Doses of Myrcludex B for 24 Weeks in Combination With Tenofovir Compared to Tenofovir Alone to Suppress HBV Replication in Patients With Chronic Hepatitis D
Chronic Hepatitis D Infection With Hepatitis B
Primary: HDV RNA Response at Week 24 — 15; 16; 23; 1 Participants — p=<.0001
Phase 3 N=150 Study to Assess Efficacy and Safety of Bulevirtide in Participants With Chronic Hepatitis Delta (CHD)
Chronic Hepatitis Delta
Primary: Percentage of Participants With Combined Response at Week 48 — 2.0; 44.9; 48.0 percentage of participants — p=<0.0001
Phase 2 N=52 A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
Hepatitis D, Chronic
Primary: Double-blind: Part 1: Percentage of Participants With HDV Ribonucleic Acid (RNA) >=2 log10 IU/mL Decline From Baseline or HDV RNA Target Not Detected (TND) in…
Phase 2 N=15 Titrating-Dose of Lonafarnib in Combination With Ritonavir
Chronic Delta Hepatitis
Primary: Change From Baseline to Week 24 in Mean Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) Titer — -1.62 log IU/mL
Phase 3 N=48 Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)
Hepatitis D, Chronic · Hepatitis B, Chronic
Primary: Number of Participants With a Virological Response — 12; 24; 9; 27 Participants
Phase 3 N=159 Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual
Hepatitis C
Primary: Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24) — 91.2 Percentage of participants
Phase 4 N=155 Adefovir Dipivoxil For The Treatment Of Patients With Chronic Hepatitis B Related Advanced Fibrosis Or Cirrhosis
Hepatitis B, Chronic · Cirrhosis · Fibrosis
Primary: Number of Participants With Histologic Improvement at Month 36 (Intent-to-Treat Population) — 52 participants
Phase 4 N=197 Efficacy and Safety Study of Tenofovir Disoproxil Fumarate (TDF) in Chinese Chronic Hepatitis B (CHB) Subjects With Advanced Fibrosis & Compensated Cirrhosis
Hepatitis B, Chronic
Primary: Incidence Rate of Newly Diagnosed Hepatocellular Carcinoma (HCC) at Week 240 — 6.045 Events per person-year
Phase 2 N=76 A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression
Hepatitis B, Chronic
Primary: Efficacy: Percent Change From Baseline in Serum Hepatitis B Surface Antigen (HBsAg) Titer at End of the Combination Treatment (Week 48) — 59.13 percent change
Phase 4 N=533 Adefovir Dipivoxil Tablets (10mg) In Chinese Subjects With HBe Antigen Negative Chronic Hepatitis B
Chronic Hepatitis B
Primary: Number of Participants Achieving HBV DNA ≤300 Copies/mL at Week 104 — 85; 403 participants
Phase 2 N=41 Lamivudine and Adefovir to Treat Chronic Hepatitis B
HBV (Hepatitis B Virus) · Hepatitis B · Hepatitis
Primary: Maintained Combined Response (Virological, Biochemical and Histological Response). — 15; 6; 7; 13 participants — p=0.0294
Phase 2 N=33 A Study to Evaluate Pegylated Interferon Lambda Monotherapy in Patients With Chronic Hepatitis Delta Virus Infection
Hepatitis D, Chronic
Primary: Change From Baseline in HDV Viral Load. — -2.14; -1.16 Change in HDV RNA log IU/mL
Phase 2 N=175 Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD)
Chronic Hepatitis Delta
Primary: Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24) — 16.7; 32.0; 46.0; 12.0 percentage of…
Phase 2 N=90 Myrcludex B in Combination With Peginterferon Alfa-2a Versus Peginterferon Alfa-2a Alone in Patients With Chronic Viral Hepatitis B With Delta-agent
Chronic Viral Hepatitis B With Delta-agent
Primary: Percentage of Patients With Negative HDV RNA by PCR — 0; 53.3; 26.7; 6.7 Percentage of participants — p=0.0022
N/A N=149 The Relationship Between Vitamin D and Hepatitis B Virus Replication
Vitamin D and Hepatitis B Virus
Primary: The Dynamic Change of HBV DNA — 3.15; 3.14 IU/mL
Phase 2 N=24 Myrcludex B Plus Pegylated Interferon-alpha-2a in Patients With HBeAg Negative HBV/HDV Co-infection
Chronic Hepatitis D Infection
Primary: Number of Participants With Hepatitis B Surface Antigen (HBsAg) Response at Week 12 of Therapy — 0; 0; 0 Participants
Phase 2 N=105 Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil
Chronic Hepatitis B
Primary: Percentage of Participants With Plasma HBV DNA < 169 Copies/mL at Week 48 — 75.5; 69.2 percentage of participants — p=.544
Phase 2 N=20 Lonafarnib With and Without Ritonavir in HDV (LOWR-1)
Chronic Hepatitis D Infection
Primary: Improvement in Quantitative Serum HDV RNA Levels After 4-12 Weeks of Lonafarnib-based Therapy — 0.03; -1.78; -1.3; -1.85 log IU/mL
Phase 2 N=13 Add-on Peginterferon Following Nucleos(t)Ide Analogue Treatment
Chronic Hepatitis B
Primary: Change in Interferon-stimulated-gene (ISG) Expression — -2.716; 1.670; -2.20; -1.597 log 2 fold change
Phase 2 N=21 Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection
Hepatitis B
Primary: Change of Serum Hepatitis B Surface Antigen (HBsAg as Measured in log10 IU/mL) Level as an Indicator of Antiviral Activity of Ledipasvir and/or Sofosbuvir in Subjects…
Phase 3 N=105 Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
Chronic Hepatitis B
Primary: Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52 — -3.69; -3.40 log10 copies/mL — p=<0.001
Phase 2 N=55 Lonafarnib Boosted With Ritonavir With and Without Peginterferon Alfa-2a (PEG IFN-a) in HDV (LOWR-2)
Chronic Hepatitis D Infection
Primary: ≥2 log10 Decline of HDV RNA From Baseline at End of Treatment (EOT) — 1; 0; 1; 0 Participants
Phase 4 N=1,470 Adefovir Dipivoxil For The Treatment Of Chinese Compensated Chronic Hepatitis B(CHB)Patients
Chronic Hepatitis B
Primary: Number of Participants Achieving HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) <1000 Copies/Milliliter at Week 48 — 341; 243; 584; 767 participants
Phase 4 N=39 A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
Hepatitis B, Chronic
Primary: Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter…