PrimaryIn HCV-infected subjects who have previously been treated with MK-5172 and received at least one dose:1. To evaluate the durability of SVR in subjects who remained HCV RNA LLoQ (either TND or TDu) throughout the follow-up period of the…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy objectives of this study are to evaluate the durability of
long-term SVR in subjects who remained HCV RNA LLoQ throughout the follow-up
period of the treatment protocol (off HCV therapy) and the evaluation of
antiviral resistance to MK-5172.
Secondary outcome
NA
Background summary
The first direct-acting antiviral (DAA) therapies for the treatment of the
hepatitis C virus (HCV) were approved in 2011 [1]. Since that time a number of
DAAs have been developed; each targeting a different phase of the viral
replication life cycle. The aim of PN 017 is to assess subjects treated with
MK-5172, a potent pangenotypic protease inhibitor, either in combination with
pegylated-interferon/ribavirin (PN 003, PN 038) or
in combination with other DAAs. Specifically the purpose is to assess the
impact of MK- 5172 containing regimens for durability of response, long-term
impact on progression of liver disease and for assessment of virologic
resistance.
PN 017 is being amended (Amendment 03) to take into consideration the updated
or emerging information regarding resistance and durability of virologic
response, as well as progression of liver disease in specialty populations.
Study objective
Primary
In HCV-infected subjects who have previously been treated with MK-5172 and
received at least one dose:
1. To evaluate the durability of SVR in subjects who remained HCV RNA LLoQ
(either TND or TDu) throughout the follow-up period of the treatment protocol
and did not start any new HCV therapy between the end of the previous protocol
and entry in this study.
All subjects (except subjects from PN 052) with HCV RNA < LLoQ will be
discontinued from PN 017 after the next scheduled visit. PN 052
subjects will remain for a duration of 5 years as introduced in AM02. Data
collected up to a subject*s last visit will be assessed for durability. After
AM03 approval, no additional subjects achieving SVR will enroll in PN 017.
2. To evaluate the presence of antiviral resistance NS3/4A, NS5A and/or NS5B,
(as appropriate) and determine if there is a reversion to a wild-type pattern
within the 3 years (all protocols except PN 052) or 5 years timeframe for PN
052 of this long-term follow-up study.
Subjects enrolling in PN 017 with quantifiable HCV RNA after having failed
therapy will be followed for 3 years (all studies except PN 052)
or 5 years (PN 052).
3. To evaluate the long term safety.
Exploratory
1. To assess liver function using the MELD and/or Child-Pugh scores for all
subjects.
2. To assess chronic kidney disease (CKD) status by assessing change in eGFR in
patients from parent Protocol 052.
3. To assess complication of CKD by recording new onset diabetes,
cryoglobulinemia, cardiovascular disease, and/or neurologic disorders (such as
stroke) in patients from parent Protocol 052.
4. To assess health outcomes by recording the occurrence of variceal bleeding,
ascites, spontaneous bacterial peritonitis, encephalopathy, hepatorenal
syndrome, hepatocellular carcinoma, liver/kidney transplantation, graft
rejection in patient who have undergone liver/kidney transplantation
Study design
This is a long term follow-up multicenter study of subjects previously treated
for chronic HCV with a MK-5172 containing regimen. There are a total of 7 (3
years) or 11 scheduled visits (5 years), depending on prior treatment trial. An
unscheduled Viral Confirmation Visit (Visit 12) is available if needed.
Monitoring will include assessment of durability of response by assaying HCV
RNA for all subjects enrolled in PN 017-00,
01 and 02.
Study burden and risks
None, except the (very small) risk of blood.
Waarderweg 39
Haarlem 2031 BN
NL
Waarderweg 39
Haarlem 2031 BN
NL
Listed location countries
Age
Inclusion criteria
1. Study subjects who previously participated in a HCV treatment protocol that includes
MK-5172 in the treatment regimen.
2. Subject must enroll (Visit 1) within three months of the last study visit (e.g. follow-up week 24) of their previous protocol in which they received an MK-5172 containing regimen.
Prior to Amendment 03, if a patient in a treatment protocol received extended followup (*1 year) in the original protocol, they may enroll in this study at the final visit of the previous protocol.
3. Subject must be * 18 years of age and willing to give written informed consent.
4. Subjects who have consented for the trial may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
5. For Amendment 03: Subjects must have received a MK-5172 containing regimen in a prior trial and have been identified as having failed therapy in that study.
Exclusion criteria
1. In the opinion of the investigator, if a subject is mentally or legally incapacitated at entry, the subject may be excluded.
2. The subject has received HCV therapy after completion of the protocol defined MK-
5172 treatment trial regimen and before or after entry into PN 017.
3. For Amendment 03: Subjects who fail therapy due to re-infection are excluded.
4. For Amendment 03: Subjects who fail therapy and receive retreatment with HCV
therapy are excluded, exceptin the case where they were re-treated in a Mercksponsored
protocol.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002232-85-NL |
| CCMO | NL51942.056.14 |