Ledipasvir and sofosbuvir for 8 weeks for the treatment of chronic hepatitis C genotype 4 in patients without cirrhosis. HepNed-001 study

Ledipasvir and sofosbuvir for 8 weeks for the treatment of chronic hepatitis C genotype 4 in patients without cirrhosis. HepNed-001 study - HepNed-001

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43387

Enrollment

Registered

2016-02-03

Start date

2016-02-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatitis C

Interventions

Ledipasvir/sofosbuvir during 8 weeks

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. >=18 years 2. Chronic HCV genotype 4 infection 3. F0-3 with biopsy or fibroscan result (stiffness

Exclusion criteria

Exclusion criteria: 1. HCV viral load > 10 million IU/ml 2. Fibroscan > 12.5 Kpa or F4 on liver biopsy or signs of portal hypertension or liver cirrhosis on imaging* 3. Disallowed co-medication that cannot be stopped or replaced 4. eGFR

Design outcomes

Primary

Measure	Time frame
Sustained viral response 12 weeks after the end of therapy (SVR12) in on-treatment study population with HCV RNA	—

Secondary

Measure	Time frame
SVR12 in ITT study population SVR12 in the population with	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)